Ba 15 ba ka Sehloohong Sepekere sa intramedullary Baetsi ba Belgium (2026 Procurement Guide)

Selelekela

Boemo ba theko ea lisebelisoa tsa bongaka lekaleng la masapo la Belgium le na le phetoho e potlakileng ea sebopeho. E tsamaisoa ke litaelo tse thata tsa ho boloka litšenyehelo tse tsoang ho Federal Public Service (FPS) Bophelo bo Botle ba Sechaba, Tšireletseho ea Lijo le Tikoloho le maemo a sithabetsang a phahameng a tsamaisoang ke marang-rang a mangata a sepetlele-joaloka ZNA/GZA (Antwerp), CHC (Liège), Grand Hôpital de Charleroi, le litsi tse etellang pele tsa thuto tsa univesithi joalo ka UZ Leuven le poraefete e ikemetseng ea St. liboto tsa thepa li etelletsa pele li-implants tse fanang ka tekanyo e nepahetseng ea ts'ebetso ea bongaka, ts'ireletso ea taolo, le tekanyetso ea tekanyetso.

Ha u laola ho robeha ha masapo a malelele, ho khetha molekane ea nepahetseng oa lipekere oa intramedullary (IM) ho bohlokoa bakeng sa ho fokotsa mathata a ka morao ho ts'ebetso le ho laola litšenyehelo tsa mekhatlo tlas'a moralo oa Belgian Overheidsopdrachten / Marchés Publics (Public Procurement Law). Tataiso ena e hlahisa Baetsi ba Top 15 Sepekere sa intramedullary ba Belgium, ba tsepamisitse maikutlo ho li-portfolio tsa bona tsa mantlha, botumo ba 'maraka, le theknoloji ea mantlha ho thusa lienjiniere tsa bongaka, lingaka tsa masapo le batsamaisi ba ketane ea phepelo ho etsa liqeto tse tsamaellanang le data.

Katoloso ea Setsebi: Ho Utloisisa Meetso e Ikhethileng Sepekere sa intramedullary Meralong ea Sejoale-joale ea Trauma Sourcing

Tlhahlobong e felletseng ea bongaka ho pholletsa le lits'ebeletso tsa bophelo bo botle tse etelletseng pele, ho reka ha masapo ho hloka kutloisiso e tebileng ea tekheniki ea mechini e kentsoeng. Lipekere tsa Intramedullary ha li sa le melamu ea tšepe e tloaelehileng; Opereishene ea sejoale-joale e hloka meralo e ikhethang ea biomechanical e lumellanang le tlhophiso e khethehileng ea fracture le pathology ea mokuli.

Ho thusa makhotla a lipetlele le likomiti tsa ho buoa ho fokotsa ts'oaetso, ho bohlokoa ho utloisisa likarolo tse ikhethileng tsa Lipekere tsa intramedullary tse laolang liholo tsa sejoale-joale tsa masapo:

1. Likopano Lipekere tsa intramedullary (Solid vs. Cannulated)

Khetho pakeng tsa meralo e tiileng le e kentsoeng ea manala e ama haholo ts'ebetso ea ho buoa le pholiso ea masapo a baeloji.

• Cannulated Lipekere tsa intramedullary  : Manala ana a na le setsi se sekoti, se lumellang hore a kenngoe holim'a terata e tataisang. Moralo ona o nolofalletsa lingaka tse buoang ho kenya reamed, e leng ho atolosa kanale ea medulla, e lumellang lenala le leholoanyane, le matla, le ho kenya likhechana tsa sebaka sa masapo ka ho toba sebakeng sa ho robeha ho potlakisa ho fola.

• E tiileng Lipekere tsa intramedullary : Haholo-holo e sebelisoa ka mekhoa e sa reroang, lipekere tse tiileng li atisa ho khethoa maemong a matla a bulehileng kapa a polytrauma ho fokotsa kotsi ea mafura a embolism le ho fokotsa tšitiso ea mali ea endosteal.

2. Cephalomedullary Nails & Proximal Femoral Systems

Bakeng sa fractures e hlahang qetellong ea femur (sebaka sa noka), lipekere tse tloaelehileng tsa ho koala ha lia lekana. Litsamaiso tse khethehileng tsa cephalomedullary lia hlokahala ho sebetsana le meroalo e feteletseng ea 'mele.

• Litlhophiso tsa Locking Locking : Meralo ena e na le masoba a ikhethileng a ka morao ho likhato tse 130 ho isa ho tse 135, tse lumellang li-screw tse boima hore li fetele ka har'a lenala ka kotloloho hloohong ea botšehali, ho boloka maqheka a subtrochanteric kapa a ipsilateral femoral shaft.

• Anti-Rotation Helical Blade Systems : E sebelisoa haholo ho robeha ha noka ea geriatric, litsamaiso tsena li nka sebaka sa li-screw tsa setso tse nang le lehare la khatello. Moralo ona o hatella lesapo le pota-potileng le hlakollang ho e-na le ho le tlosa, ho fokotsa haholo kotsi ea 'cut-out' ho lesapo la osteoporotic.

3. Retrograde vs. Anterograde Long-Bone Nails

Ho itšetlehile ka sebaka sa ho robeha le botšepehi ba lisele tse bonolo, lingaka tse buoang li tlameha ho khetha li-portal tsa ho kena tse fapaneng bakeng sa ho kenya manala.

• Anterograde Sourcing : Li-implants tse kentsoeng ho tloha qetellong ea proximal (mohlala, ho kena ka har'a trochanter bakeng sa ho robeha ha botšehali). Sena se hloka hore manala a khumame ho tsamaisana le makhopho a tlhaho.

• Retrograde Sourcing : Li-implants tse kentsoeng ho tloha pheletsong ea distal (mohlala, ho kena ka holim'a lengole feela). Lipekere tse khethehileng tsa retrograde femoral li na le mekhoa e ikhethang ea ho notlela distal ho boloka fractures e rarahaneng ea distal third supracondylar.

Li-Giants tsa Indasteri ea Lefatše le Li-brand tse etelletseng pele

1. Stryker Corporation

Sebapali se hlahelletseng marang-rang a univesithi ea tier-1 ea Belgium le litsing tsa batho ba sithabetsang maikutlo, Stryker e thehiloeng US e hlomphuoa haholo ka boenjiniere ba eona bo nepahetseng le tšehetso e matla ea khoebo.

• Lihlahisoa tsa mantlha: Liphetoho tse kopanetsoeng, li-platform tse thusoang ke liroboto (Mako), lisebelisoa tsa neurotechnology, le mekhoa e tsoetseng pele ea ho lokisa mahlomola.

• Core Portfolio: The Gamma4 Trochanteric Nail System le T2 Alpha Interlocking Nail System e fana ka botsitso bo tsoetseng pele ba mochini le litlhophiso tsa lisebelisoa tse lebisitsoeng.

2. DePuy Synthes (Johnson & Johnson MedTech)

Kaha DePuy Synthes e na le boemo bo metseng ka metso ho mafapha a lipetlele tsa sechaba le tsa poraefete naheng ea Belgium, e sebelisa lilemo tse mashome tsa lipatlisiso tsa bongaka tse tšehelitsoeng ke AO Foundation.

• Lihlahisoa tsa mantlha: Mekhoa e felletseng ea ts'oaetso, litharollo tsa kaho e kopaneng, lisebelisoa tsa craniomaxillofacial, le li-biomaterials tsa mokokotlo.

• Core Portfolio: Setsebi sa Nail System le TFNA (Trochanteric Fixation Nail Advanced) li sebelisa mekhoa ea phekolo ea tšepe e ntlafalitsoeng bakeng sa ho robeha ha masapo a trochanteric le a malelele.

3. CZMEDITECH

E le setsi se tsebahalang lefatšeng ka bophara lisebelisoa tsa bongaka tsa masapo, CZMEDITECH e thehile sebaka sa phepelo se ntseng se hola 'marakeng oa Benelux, haholo ka hare ho Belgium. E tsebahala ka ho koala lekhalo lipakeng tsa boenjiniere bo nepahetseng ba boemo ba Jeremane le katleho e phahameng ea tlholisano ea tlhahiso, k'hamphani e fana ka sethala se felletseng sa ts'oaetso se tšoereng tumello e tiileng ea bongaka ea machaba-ho kenyeletsoa ISO 13485, CE , mangolo-ho e etsa molekane ea loketseng bakeng sa bophelo bo botle ba Hôitaires Universitaire / Universitaire Universitaux. marang-rang a batlang ho ntlafatsa theko ea theko e phahameng ho latela litaelo tsa European Public Procurement.

• Mekhoa ea Meriana ea Meriana ea Meriana: Ho Kopana ho Tsoetseng Pele Lipekere tsa intramedullary , Anatomical Locking plates & Screw, le Lits'ebetso tsa ho Lokisa ka Ntle.

• Litharollo tsa ho Lokisoa ha Mokokotlo : Anterior / Posterior Cervical & Thoracolumbar Systems, Interbody Fusion Cages, le Spinal Fixation Rods.

• Cranio-Maxillofacial ( CMF ) Li-implants : Litlaleho tsa Titanium tsa boemo bo tlaase haholo le Letlooa Mekhoa ea ho tsosolosa sefahleho.

• Lisebelisoa le Lisebelisuoa tsa Matla a ho Buoa: Ts'ebetso e phahameng Boro ea masapo s, Li-Saw tse Oscillating, le lisebelisoa tse tsamaellanang tsa sterilization.

• Litšebeletso tse Khethehileng OEM/ODM : Ho etsoa ha lisebelisoa tsa bongaka tsa ho qetela ho tsamaellana le litlhaloso tsa lipetlele tsa lefats'e.

• Core IM Nail Portfolio & Lihokelo:

  • Femoral Sepekere sa intramedullary : E entsoe ho tloha ho implant-grade Titanium Alloy (Ti-6Al-4V ELI), e nang le optimized anatomical curvature le multi-planar locking configurations ho fana ka tlhophiso e thata bakeng sa fractures e rarahaneng ea shaft.

  • Tibial Sepekere sa intramedullary : E entsoe ka likhetho tse tsoelang pele tsa ho notlela tse matla le profil e kentsoeng, e khothalletsang ho jara boima ba 'mele le ho potlakisa pholiso ea masapo.

  • Humeral Sepekere sa intramedullary : Tharollo e khethehileng e ka holimo-limo e tsamaisang mokhoa o fokolang, ho fokotsa ho senyeha ha lisele tse bonolo le ho sireletsa cuff ea rotator.

  • Proximal Femoral Nail Antirotation - PFNA : E na le sistimi ea helical blade e ntlafalitsoeng bakeng sa bakuli ba tsofetseng ba nang le meaho ea masapo a masapo, e netefatsang khanyetso e phahameng khahlanong le sehiloeng nakong ea trochanteric fracture fixation.

4. Zimmer Biomet Holdings, Inc.

Zimmer Biomet e kopanya li-platform tsa tlhokomelo ea bophelo bo botle ba dijithale ka theknoloji ea ho lokisa mesifa le masapo, e sebeletsang marang-rang a maholo a bophelo bo botle ho pholletsa le Brussels, Flanders le Wallonia.

• Lihlahisoa tsa mantlha: Metrics ea bophelo bo botle ba dijithale e tsamaellanang, ho nkeloa sebaka ka kopanelo, lisebelisoa tsa meriana ea lipapali, le li-implants tsa trauma.

• Core Portfolio: The Natural Nail System e na le li-curvature tsa anatomical tse etselitsoeng ho lumellana le mefuta e fapaneng ea li-morphology ho pholletsa le palo ea batho ba Europe.

5. Smith & Nephew plc

Ka ts'ebetso e sebetsang e tobileng le li-hubs tse matla tsa thepa ho pholletsa le Europe Bophirimela, Smith & Nephew ea UK-based o ipabola ka tlhokomelo e tsoetseng pele ea maqeba le mekhoa e khethehileng ea ho sithabela maikutlo.

• Lihlahisoa tse ka sehloohong: Mekhoa e tsoetseng pele ea tsamaiso ea maqeba, lisebelisoa tsa pono ea arthroscopy, le lisebelisoa tsa ts'oaetso ea masapo.

• Core Portfolio: The TRIGEN Interlocking Nail System e na le lisebelisoa tse khethehileng tsa holim'a metsi tse ntlafalitsoeng bakeng sa taolo e matla ea maoto le matsoho a tlase.

6. B. Braun Melsungen AG (Aesculap)

E emela boenjiniere ba boemo bo phahameng ba Jeremane bo nang le khoebo e matla ka mokhoa o makatsang le maqhama a tebileng a lehae naheng ea Belgium (e nang le liofisi tsa bohlokoa Diegem), B. Braun e fana ka litsi tsa kliniki tsa Belgian tse nang le ts'ebetso e ikhethang e tšoarellang, e nepahetseng-e entsoeng ka mokhoa o nepahetseng.

• Lihlahisoa tsa mantlha: Mekhoa ea phekolo ea infusion, lisebelisoa tsa ho buoa, li-implants tsa mokokotlo, le lisebelisoa tsa ts'oaetso ea sebopeho.

• Core Portfolio: Targon Interlocking Nail System e fana ka ts'ebetso e phahameng ea ho notlela bakeng sa ho batla ho tsosolosoa ha marapo a malelele a femur le tibia.

7. Medtronic plc

Le hoja e le ea bohlokoa haholo ho li-pacemaker le lisebelisoa tsa mokokotlo, Medtronic's structural osteo-division e fana ka litlhoko tse rarahaneng tsa ho lokisa likotsi tse ngata ka har'a lihlopha tsa sepetlele sa Belgian.

• Lihlahisoa tsa mantlha: Lisebelisoa tsa mokokotlo, li-platform tse tsoetseng pele tsa ho sesa, lisebelisoa tsa neurosurgery, le li-implants tse khethehileng tsa ts'oaetso.

• Core Portfolio: Meralo ea lisebelisoa tse feto-fetohang tse kopantsoeng le litlhophiso tse hokahaneng tsa bokahohleng tse loketseng kaho e phahameng ea marapo.

8. Orthofix Medical Inc.

Orthofix e ipabola ka ho kopanya lifilosofi tsa ho lokisa ka hare le kantle, e fana ka likhetho tse ikhethang tsa ntlafatso ea baeloji bakeng sa litsebi tsa masapo ho pholletsa le Belgium.

• Lihlahisoa tsa mantlha: Liforeimi tsa ho lokisa ka ntle, liphekolo tse matlafatsang ho hola ha masapo, le likopano tse khethehileng tsa intramedullary tsa ho lelefatsa maoto le matsoho.

• Core Portfolio: Litsamaiso tse khethehileng tsa bana le batho ba baholo ba nang le lipekere tse shebaneng le ho laola bofokoli bo matla ba intertrochanteric kapa shaft bone.

9. Acumed LLC

Acumed e shebana le ho nepahala ha tlhaho bakeng sa fractures e ka holimo, e fana ka lisebelisoa tse khethehileng tse ratoang ke litsebi tsa matsoho le maoto a ka holimo ho marang-rang a ka sehloohong a Belgium.

• Lihlahisoa tse ka Sehloohong: Anatomical Locking plates , lisebelisoa tse khethehileng tsa osteotomy, le li-rods tse lebisitsoeng tsa intramedullary tse ka holimo-limo.

• Core Portfolio: Manala a ka tlase a humeral intramedullary le forearm rods tse etselitsoeng ho fokotsa ho kenella ha lisele tse bonolo.

10. Globus Medical, Inc.

Ka mor'a ho kopana ha morao tjena boemo bo phahameng le NuVasive, Globus Medical e atolositse ka potlako boemo ba eona ba mahlomola le ho tsosolosa marang-rang a lipetlele Europe Bophirimela.

• Lihlahisoa tsa mantlha: Litharollo tse felletseng tsa musculoskeletal, hardware e tsoetseng pele ea mokokotlo, le ts'ebetso ea ts'oaetso ea liroboto.

• Core Portfolio: The CAPTIVATE Trauma System, e nang le lisebelisoa tse lokiselitsoeng hantle tse etselitsoeng ho hokahana hantle ha femur le tibia.

11. Wright Medical Group NV (Khamphani ea A Stryker)

E sebetsa ka har'a lelapa la ts'oaetso ea Stryker, lefa la Wright Medical le tlaase le thepa ea maoto le maqaqailana e ntse e le khetho e ka holimo bakeng sa ho tsosolosoa ho rarahaneng le ho kopanya Belgium.

• Lihlahisoa tse ka Sehloohong: Li-implants tse ka holimo, ho nkeloa sebaka ka kakaretso ha maqaqailana, le li-graft tse tsoetseng pele tsa masapo a orthobiologic.

• Core Portfolio: Li-retrograde retrograde hindfoot le maqaqailaneng a fusion rods tse etselitsoeng liopereishene tse rarahaneng tsa arthrosis.

12. Aap Implantate AG

Aap Implantate ke moetsi ea thehiloeng Jeremane ea tsebahalang bakeng sa ho hlahisa liphahlo tsa silevera le mahlale a ho notlela a antibacteria a etselitsoeng ho fokotsa ts'oaetso e amanang le implant.

• Lihlahisoa tsa mantlha: Thepa ea LOQTEQ Locking plate ea lelapa le li-implants tsa antibacterial tse koahetsoeng ka silevera.

• Core Portfolio: Sistimi e kentsoeng ka makotikoting le e tiileng ea titanium e hahelletsoeng ho fokotsa mathata a kamora ts'ebetso nakong ea ho kenella ha masapo a malelele.

13. CarboFix Orthopedics Ltd.

CarboFix ke pula-maliboho ho thekenoloji ea carbon-fiber, e fanang ka tlhahiso ea boleng bo ikhethang bakeng sa liopereishene tsa masapo tse amanang le oncology ho pholletsa le likarolo tse khethehileng tsa mofets'e tsa Belgium.

• Lihlahisoa tsa mantlha: Lipoleiti tsa polymer tse matlafalitsoeng ka carbon fiber, lipekere tsa khabone ea sebopeho, le li-implants tsa trauma ea radiolucent.

• Core Portfolio: Piccolo Composite Nails, e lumellang litšoantšo tse hlakileng, tse se nang li-artifact nakong ea tatellano ea oncological le sepheo sa kalafo ea radiation.

14. MicroPort Scientific Corporation

Ka ho sebelisa lits'ebetso tse atolositsoeng tsa indasteri, MicroPort e tsamaisa likhetho tse theko e tlaase, tse phahameng haholo tsa pelo le methapo ea kutlo ho pholletsa le liteishene tsa Europe Bophirima ho fihlela litekanyetso tse thata tsa lichelete tsa sepetlele.

• Lihlahisoa tsa mantlha: Li-stents tse fokolang tsa pelo, li-prostheses tse kopantsoeng, le lisebelisoa tse feletseng tsa ho lokisa mahlomola.

• Core Portfolio: Lits'ebetso tse hokahaneng tsa lipekere tsa intramedullary tse etselitsoeng mekhoa e pheta-phetoang, e bonolo ea ho kenya.

15. Wego Ortho (Weigao Group)

Wego Ortho ke e 'ngoe ea lik'hamphani tse kholo ka ho fetisisa tsa bongaka tsa Asia, tse fanang ka li-implants tse ka tšeptjoang haholo tse khotsofatsang litlhoko tse matla tsa bongaka tsa Europe.

• Lihlahisoa tsa mantlha: Lisebelisoa tsa ho lokisa mokokotlo, lipoleiti tsa ts'oaetso ea sebopeho, li-prostheses tse kopantsoeng, le lisebelisoa tsa ho buoa tse nyopa.

• Core Portfolio: Lethathamo le pharaletseng la manala a tšoarellang a titanium a lohelletsoeng bakeng sa lithendara tsa sehlopha sa sepetlele sa sechaba sa Belgium.

Katoloso ea Setsebi: Ho Utloisisa Meetso e Ikhethileng Sepekere sa intramedullary Meralong ea Sejoale-joale ea Trauma Sourcing

Tekolong e felletseng ea bongaka ho pholletsa le lits'ebeletso tsa bophelo bo botle tsa Europe, ho reka ha masapo ho hloka kutloisiso e tebileng ea botekgeniki ea mechini e kentsoeng. Lipekere tsa Intramedullary ha li sa le melamu ea tšepe e tloaelehileng; Opereishene ea sejoale-joale e hloka meralo e ikhethang ea biomechanical e lumellanang le tlhophiso e khethehileng ea fracture le pathology ea mokuli.

Ho thusa makhotla a lipetlele le likomiti tsa ho buoa ho fokotsa ts'oaetso, ho bohlokoa ho utloisisa likarolo tse ikhethileng tsa Lipekere tsa intramedullary tse laolang liholo tsa sejoale-joale tsa Europe:

1. Likopano Lipekere tsa intramedullary (Solid vs. Cannulated)

Khetho pakeng tsa meralo e tiileng le e kentsoeng ea manala e ama haholo ts'ebetso ea ho buoa le pholiso ea masapo a baeloji.

• Cannulated Lipekere tsa intramedullary : Manala ana a na le setsi se sekoti, se lumellang hore a kenngoe holim'a terata e tataisang. Moralo ona o nolofalletsa lingaka tse buoang ho kenya reamed, e leng ho atolosa kanale ea medulla, e lumellang lenala le leholoanyane, le matla, le ho kenya likhechana tsa sebaka sa masapo ka ho toba sebakeng sa ho robeha ho potlakisa ho fola.

• E tiileng Lipekere tsa intramedullary : Haholo-holo e sebelisoa ka mekhoa e sa reroang, lipekere tse tiileng li atisa ho khethoa maemong a matla a bulehileng kapa a polytrauma ho fokotsa kotsi ea mafura a embolism le ho fokotsa tšitiso ea mali ea endosteal.

2. Cephalomedullary Nails & Proximal Femoral Systems

Bakeng sa fractures e hlahang qetellong ea femur (sebaka sa noka), lipekere tse tloaelehileng tsa ho koala ha lia lekana. Litsamaiso tse khethehileng tsa cephalomedullary lia hlokahala ho sebetsana le meroalo e feteletseng ea 'mele.

• Litlhophiso tsa Locking Locking: Meralo ena e na le masoba a ikhethileng a ka morao ho likhato tse 130 ho isa ho tse 135, tse lumellang li-screw tse boima hore li fetele ka har'a sepekere ka kotloloho hloohong ea botšehali, ho boloka maqheka a subtrochanteric kapa a ipsilateral femoral shaft.

• Anti-Rotation Helical Blade Systems: E sebelisoa haholo ho robeha ha noka ea geriatric, litsamaiso tsena li nka sebaka sa li-screw tsa setso tse nang le lehare la khatello. Moralo ona o hatella lesapo le pota-potileng le hlakollang ho e-na le ho le tlosa, ho fokotsa haholo kotsi ea 'cut-out' ho lesapo la osteoporotic.

3. Retrograde vs. Anterograde Long-Bone Nails

Ho itšetlehile ka sebaka sa ho robeha le botšepehi ba lisele tse bonolo, lingaka tse buoang li tlameha ho khetha li-portal tsa ho kena tse fapaneng bakeng sa ho kenya manala.

• Anterograde Sourcing: Li-implants tse kentsoeng ho tloha pheletsong e haufi (mohlala, ho kenya trochanter bakeng sa ho robeha ha botšehali). Sena se hloka hore manala a khumame ho tsamaisana le makhopho a tlhaho.

• Retrograde Sourcing: Li-implants tse kentsoeng ho tloha pheletsong e ka thoko (mohlala, ho kena ka holim'a lenonyeletso la lengole). Lipekere tse khethehileng tsa retrograde femoral li na le mekhoa e ikhethang ea ho notlela distal ho boloka fractures e rarahaneng ea distal third supracondylar.

── PRODUCT SELECTION MATRIX ──

Lipotso tse atisang ho botsoa (FAQ)

Q1: Na lipekere tsa intramedullary tse hlokahalang bakeng sa 'maraka oa Belgian li hloka CE Ho tšoaea tlas'a EU MDR?

E, ruri. Ho latela ts'ebetsong e tiileng ea European Medical Device Regulation (MDR 2017/745), lipekere tsohle tsa intramedullary tse rekisoang Belgium li tlameha ho ba le letšoao le nepahetseng la CE tlas'a tataiso ea MDR . Sehlopha sa IIb le Sehlopha sa III Li-implant tsa masapo se tobane le tlhahlobo e matla ea bongaka, litlhahlobo tsa litokomane tsa tekheniki, le ts'ebetso e matla ea kamora 'maraka (PMCF). Batsamaisi ba Theko ba tlameha ho etsa bonnete ba hore moetsi leha e le ofe oa machaba, joalo ka CZMEDITECH , o fana ka Phatlalatso ea Conformity mme o ngolisitsoe ka botlalo ka har'a database ea EUDAMED .

Q2: Ke litlhoko life tse ikhethileng tsa ho ingolisa le FAMHP / FAGG?

Leha ho na le Letšoao le sebetsang la CE , sesebelisoa leha e le sefe sa bongaka se ajoang kapa se rekisoang ka har'a Belgium se tlameha ho tsebisoa le ho ngolisoa polokelong ea naha e laoloang ke FAMHP (Federal Agency for Medicines and Health Products) / FAGG (Federaal Agentschap voor Geneesmidelen en Gezondheidsproducten) . Barekisi, barekisi, kapa baemeli ba nang le tumello ea lehae ba tlameha ho ngolisa lihlahisoa ka portal ea inthaneteng pele ba ka nka karolo ka molao ho lithendara tsa marangrang a lipetlele tsa sechaba.

Q3: Ke hobane'ng ha litsamaiso tsa Helical Blade (joaloka PFNA) li etelletsoa pele haholo marang-rang a sepetlele sa Belgian (mohlala, ZNA, UZ Leuven)?

Belgium e na le palo ea batho ba tsofalang ka potlako, e leng se lebisang keketsehong ea ho robeha ha litho tsa botšehali ho proximal proximal femoral. Likurufu tsa khale tsa lag hangata li hloleha ka 'cut-out' ea mochini lesapong le fokolang. Ho fumana lits'ebetso tse tsoetseng pele joalo ka CZMEDITECH 's PFNA, e sebelisang lehare le matla la helical ho hatella ho fapana le ho phunya lisele tsa masapo, e eketsa botsitso ba ho potoloha le ho thibela haholo ho bala lipetlele tse theko e boima le lintlafatso - litekanyetso tsa bohlokoa tsa lintlha ho lithendara tse kopaneng tsa marang-rang a lipetlele tse ngata.

Q4: Ho kopanngoa ha marang-rang a sepetlele sa Belgian ho ama joang ho fumana lipekere tsa IM?

Sebopeho sa mehleng ea kajeno sa Belgian se hlalosoa haholo ka ho kopanngoa ha lipetlele ho ea ka marang-rang a libaka (mohlala, marang-rang a 13 a kliniki Flanders le Wallonia). Marang-rang ana a etsa lithendara tse kholo, tse nang le libaka tse ngata tlas'a melaoana ea Overheidsopdrachten / Marchés Publics , e shebaneng haholo le Theko e Thehiloeng ka Boleng . Lithendara li lekola makhabane a tekheniki (joalo ka ho lumellana le mochini oa Titanium ea Kereiti ea 5, lintlha tsa polokeho ea thepa e tala, le lisebelisoa tsa ergonomics) hammoho le ts'ebetso ea lichelete. Baetsi ba fanang ka liprofaele tsa maemo a holimo tse nang le tšebetso e ntle (joalo ka CZMEDITECH ) ba hlolisanoa haholo ka ho hapa likonteraka tsena tsa lilemo tse ngata.

Q5: Ke taolo efe le taolo ea puo e hlokahalang bakeng sa li-implants ka har'a lipetlele tsa Belgian?

Belgium e tiisa ka thata tsamaiso ea UDI (Unique Device Identification) tlas'a taelo ea EU, e netefatsa hore ho na le ts'ebetso e feletseng ho tloha ho moetsi ho ea ho rekoto e khethehileng ea bophelo bo botle ba mokuli ( Elektronisch Patiëntendossier / Dossier Médical Électronique ). Ho feta moo, Litaelo tsohle tsa Tšebeliso (IFU), li-laible, le litataiso tsa ho buoa li tlameha ho lumellana ka thata le litlhoko tsa lipuo tse tharo tsa Belgium (Dutch, French, and English), ho itšetlehile ka sebaka sa sebaka seo marang-rang a sepetlele a leng ho sona.

Q6: Na marang-rang a sepetlele sa Belgian a ka kopanya mela e mengata ea mahlomola ho tsoa ho moetsi a le mong oa machaba?

E, 'me sena se khothaletsoa haholo bakeng sa litšenyehelo le ntlafatso ea tsamaiso. Ho kopanya mela ea mahlomola ka molekane a le mong ea tobileng kapa mofani ea lumelletsoeng oa mohloli o le mong ho lumella marang-rang a kopantsoeng a sepetlele sa Belgian ho rua molemo moruong o moholo. Ho fumana chelete ho tsoa ho moetsi ea kopantsoeng joaloka CZMEDITECH ho lumella marang-rang a sepetlele hore a fumane Femoral Nails, Tibial Nails, anatomical Locking plates , le Lisebelisoa tsa motlakase tsa bongaka ka nako e le' ngoe-ho ntlafatsa tsamaiso ea li-invoice tsa tsamaiso, ho fokotsa mehato ea carbon e amanang le thepa, le ho etsa bonnete ba hore mekhoa e tloaelehileng ea lisebelisoa tsa ho buuoa ho pholletsa le marang-rang a marang-rang.

Qetello

Le ha lihlahisoa tsa setso tsa Amerika Leboea le Europe Bohareng li ntse li tsoela pele ho ba le likarolo tsa bohlokoa tsa mmaraka marang-rang a tier-1 a Belgium, likhatello tse ntseng li eketseha tsa lichelete mabapi le lichelete tsa bophelo bo botle ba sechaba li entse hore ho be le bahlahisi ba tsofetseng, ba netefalitsoeng lefatšeng ka bophara. Bafani ba rata CZMEDITECH fana ka tlhahiso ea boleng bo matla haholo bakeng sa likarolo tsa morao-rao tsa Belgium ka ho bapisa litifikeiti tsa pele tsa bongaka tsa Europe ( CE / ISO ) le lisebelisoa tse tala tsa boemo bo holimo tse nang le meaho ea tlhahiso e ntlafalitsoeng haholo.