Top 15 Intramedullary nail Nnwumayɛfoɔ a wɔwɔ Bulgaria (2026 Adetɔ ho Akwankyerɛ)

Nnianimu

Aduruyɛ mfiri a wɔtɔ wɔ Bulgaria nnompe ho adwumayɛbea no renya nkɔso ntɛmntɛm wɔ nhyehyɛe mu. Wɔde ahyehyɛde ahorow a wɔde di dwuma yiye ho ahyɛde ahorow a efi Akwahosan Dwumadibea ( Министерство на здравеопазването ) ne adwenemhaw dodow a ɛkɔ soro a sukuupɔn ahorow akɛse ne ayaresabea atitiriw a ɛhwɛ Ɔman Akwahosan Insurance Foto ( НЗОК ) ase—te sɛ Pirogov Emergency Hospital (Sofia), MHAT—na ɛkanyan no 'St. Anna' (Sofia), Sukuupɔn Ayaresabea 'St. George' (Plovdiv), ne Koma ne Amemene Asoɛe a ɛyɛ den kɛse (Burgas ne Pleven), a ɛka ankorankoro ayaresabea akuw a ɛyɛ fɛ te sɛ Acibadem City Clinic ne Vita ho—ayaresabea adetɔ bagua ahorow de nneɛma a wɔde hyɛ nipadua mu a ɛma wonya ayaresa mu mmɔdenbɔ, mmara mu ahobammɔ, ne sikasɛm nhyehyɛe a ɛkari pɛ a eye sen biara di kan.

Sɛ woredi nnompe atenten a abubu ho dwuma a, ɛho hia sɛ wɔpaw intramedullary (IM) nnadewa hokafo a ɔfata na ama wɔatew oprehyɛn akyi nsɛnnennen so na wɔadi ahyehyɛde no ka ho dwuma wɔ Bulgaria Ɔmanfo Adetɔ Mmara ( Закон за обществените поръчки - ЗОП ). Saa akwankyerɛ yi kyerɛ Top 15 Intramedullary nail Manufacturers wɔ Bulgaria, ɛde n’adwene si wɔn portfolio titire, gua so din, ne mfiridwuma titire so de boa biomedical engineers, nnompe oprehyɛn ho animdefoɔ, ne supply chain managers ma wɔsi gyinaeɛ a egyina data so.

Mfiridwuma mu Ntrɛwmu: Intramedullary nail Nsusuwii Titiriw a Wɔyɛ wɔ Nnɛyi Trauma Sourcing mu ntease

Wɔ aduruyɛ mu tender nhwehwɛmu a edi mũ mu wɔ akwahosan ho mmeae atitiriw nyinaa mu no, nnompe mu ahodwiriw a wɔbɛtɔ no hwehwɛ sɛ wonya mfiridwuma mu ntease a emu dɔ wɔ mfiri a wɔde hyɛ nipadua mu ho. Nnadewa a ɛwɔ medullary mu no nyɛ dade abaa a wɔde di dwuma wɔ ɔkwan biara so bio; nnɛyi oprehyɛn hwehwɛ sɛ wɔyɛ biomechanical nhyehyɛe ahorow a ɛyɛ soronko koraa a wɔayɛ ama sɛnea abubu no nhyehyɛe pɔtee ne ɔyarefo no yare.

Sɛnea ɛbɛyɛ na wɔaboa ayaresabea baguafo ne oprehyɛn boayikuw ahorow ma wɔayɛ adwenemhaw a wonya fi mu no yiye no, ɛho hia sɛ yɛte Intramedullary nail ahorow akuw titiriw titiriw a ɛhyɛ nnɛyi nnompe ho agoprama ahorow so no ase:

1. Nkitahodi Intramedullary nail ahorow (Solid vs. Cannulated) .

Nnadewa a ɛyɛ den ne nea wɔde kankyee ayɛ a wɔpaw no nya oprehyɛn adwumayɛ ne nnompe a nkwa wom ayaresa so nkɛntɛnso kɛse.

• Cannulated Intramedullary nail ahorow  : Saa nnadewa yi wɔ mfinimfini a ɛyɛ tokuru, na ɛma wotumi de hyɛ wayam a ɛkyerɛ kwan so. Saa nhyehyɛe yi ma nnuruyɛfo a wɔyɛ oprehyɛn tumi yɛ reamed insertion, a ɛtrɛw medullary canal no mu, ɛma wonya nnadewa kɛse a ɛyɛ den, na ɛde mpɔtam hɔ nnompe a wɔde ahyɛ mu asinasin no kɔ baabi a abubu no tẽẽ na ama ayaresa no ayɛ ntɛmntɛm.

• Solid Intramedullary nail ahorow : Wɔde di dwuma titiriw wɔ akwan a wɔmfa nhyɛ mu, na wɔtaa paw nnadewa a ɛyɛ den wɔ akisikuru a emu yɛ den a abue anaasɛ polytrauma nsɛm mu de atew asiane a ɛwɔ hɔ sɛ srade a ɛwɔ nipadua no mu no so na wɔatew endosteal mogya a wɔde ma no mu ɔhaw so.

2. Cephalomedullary Nails & Asen mu Nneɛma a Ɛbɛn

Wɔ akisikuru a ɛba wɔ asen no awiei a ɛbɛn (asen no fã) fam no, nnadewa a ɛka bom a wɔtaa de di dwuma no nnɔɔso. Wɔhwehwɛ sɛ wɔde cephalomedullary nhyehyɛe titiriw bi di nipadua mu adesoa a emu yɛ den ho dwuma.

• Reconstruction Locking Configurations : Saa nhyehyɛe ahorow yi wɔ proximal tracking holes titiriw a wɔayɛ no anim bɛyɛ digrii 130 kosi 135, na ɛma lag screws a emu yɛ duru fa nnadewa no mu kɔ asen no ti no mu tẽẽ, na ɛbɔ subtrochanteric anaa ipsilateral femoral shaft fractures ho ban.

• Anti-Rotation Helical Blade Systems : Wɔde di dwuma titiriw wɔ geriatric hip fractures mu, saa nhyehyɛe ahorow yi de compression blade si atetesɛm lag screws ananmu. Saa nhyehyɛe yi mia dompe a atwa ho ahyia a ɛyɛ cancellous no sen sɛ ebeyi afi hɔ, na ɛtew asiane a ɛwɔ hɔ sɛ wɔde 'twitwa' bɛhyɛ dompe a ɛyɛ nnompe mu no so kɛse.

3. Nnadewa a Nnompe Tenten a Ɛkɔ Akyi ne Anterograde

Ɛsɛ sɛ nnuruyɛfo a wɔyɛ oprehyɛn no gyina beae a abubu ne sɛnea ntini a ɛyɛ mmerɛw no mudi mu kura so paw apon a ɛne ne ho bɔ abira a wɔde hyɛn mu a wɔde nnadewa bɛhyɛ mu.

• Anterograde Sourcing : Nneɛma a wɔde hyɛ nipadua mu a wɔde fi proximal awiei (sɛ nhwɛso no, ɛhyɛn trochanter no mu ma asen mu abubu). Eyi hwehwɛ sɛ wɔde nnadewa kotow pɛpɛɛpɛ na ama ɛne abɔde mu nipadua a ɛyɛ kurukuruwa ahyia.

• Retrograde Sourcing : Nneɛma a wɔde hyɛ nipadua mu a wɔde fi akyirikyiri awiei (sɛ nhwɛso no, ɛhyɛn kotodwe nkwaa no atifi pɛɛ). Nnadewa titiriw a ɛkɔ akyi a ɛwɔ akyi no wɔ akwan soronko a wɔfa so to akyirikyiri de bɔ akyirikyiri a ɛyɛ den a ɛto so abiɛsa a ɛwɔ akyi no ho ban.

Wiase Nyinaa Nnwuma akɛse & Nneɛma a Wɔde Di Dwuma

1. Stryker Adwumakuw no

Ɔyɛ obi a ɔyɛ adwuma titiriw wɔ Bulgaria sukuupɔn nkitahodibea ahorow a ɛwɔ tier-1 ne mmeae titiriw a wɔyɛ ahodwiriwde mu, na wobu Stryker a ɛwɔ U.S. no kɛse wɔ ne mfiridwuma a ɛyɛ pɛpɛɛpɛ ne aguadi mmoa a emu yɛ den no ho.

• Nneɛma Titiriw a Wɔde Yɛ: Nneɛma a wɔde si nkwaa ananmu, mfiri a wɔde robɔt boa (Mako), mfiri a wɔde yɛ ntini mu mfiridwuma, ne nhyehyɛe a ɛkɔ anim a wɔde siw adwenemhaw ano.

• Core Portfolio: Gamma4 Trochanteric Nail System ne T2 Alpha Interlocking Nail System no ma mfiridwuma mu ahoɔden a ɛkɔ anim ne nnwinnade nhyehyɛe a wɔde asi wɔn ani so.

2. DePuy Synthes (Johnson ne Johnson MedTech) Ɔkwan a wɔfa so yɛ adwuma no.

Esiane sɛ DePuy Synthes kura gyinabea a agye ntini kɛse wɔ ɔman ne ankorankoro ayaresabea ahorow nyinaa mu wɔ Bulgaria nti, ɔde mfe du du pii a wɔde ayɛ ayaresabea nhwehwɛmu a AO Fapem no gyina akyi no di dwuma.

• Nneɛma Titiriw a Wɔde Yɛ: Apirakuru nhyehyɛe a edi mũ, nkwaa a wɔsan yɛ no ano aduru, craniomaxillofacial mfiri, ne akyi berɛmo mu biomaterials.

• Core Portfolio: Expert Nail System ne TFNA (Trochanteric Fixation Nail Advanced) de dade ayaresa a ɛyɛ wɔn de a wɔayɛ no yiye ama trochanteric ne nnompe atenten a ɛpaapae a ɛyɛ den di dwuma.

3. CZMEDITECH

Sɛ́ tumi kɛse a wogye tom wɔ wiase nyinaa wɔ nnompe mu nnuruyɛ mu no, . CZMEDITECH de nneɛma a wɔde ma a ɛretrɛw wɔ Europa Apuei Fam gua so asi hɔ, titiriw wɔ Bulgaria mu. Adwumakuw no agye din sɛ ɛma nsonsonoe a ɛda Germanfo mfiridwuma a ɛyɛ pɛpɛɛpɛ a ɛyɛ fɛ ne nneɛma a wɔyɛ no yiye a akansi kɛse wom ntam no ano, na ɛde adwenemhaw ho nhyehyɛe a edi mũ a ɛkura amanaman ntam aduruyɛ ho tumi krataa a emu yɛ den ma— ISO 13485, CE adansedi nkrataa ka ho—a ɛma ɛyɛ ɔhokafo a ɔfata ma ɔman ayaresabea akɛse a wɔhwɛ ntɛmpɛ ne ankorankoro akwahosan ho nhyehyɛe ahorow a wɔhwehwɛ sɛ wɔbɛyɛ nea eye sen biara adetɔ a ɛkɔ soro wɔ EU Ɔmanfo Adetɔ akwankyerɛ ahorow ase.

• Nnompe mu Apirakuru Nhyehyɛe: Advanced Interlocking Intramedullary nail ahorow , Nkwammoaa ho nsɛm Locking plates & Nkuruwankuruwa, ne Abɔnten so Nneɛma a Wɔde Siesie Nneɛma.

• Akyi berɛmo a Wɔde Siesie Ano Aduru : Anim/Akyi Awotwaa & Thoracolumbar Systems, Interbody Fusion Cages, ne Akyi berɛmo a Wɔde Sisi Nnua.

• Cranio-Maxillofacial ( CMF ) Implants : Titanium Mprɛte a ɛba fam yiye ne Ntwene Nhyehyɛe a wɔde san yɛ anim.

• Oprehyɛn Tumi Nnwinnade & Nneɛma a Wɔde Di Dwuma: Ortopedik dril s a ɛyɛ adwuma yiye, Oscillating Saws, ne sterilization instrument kits a ɛne no hyia.

• Customized OEM/ODM Services : Aduruyɛ mfiri a wɔyɛ fi awiei kosi awiei a wɔayɛ no sɛnea wiase nyinaa ayaresabea nkyerɛkyerɛmu te.

• Core IM Nail Portfolio & Nkitahodi ahorow:

  • Femoral Intramedullary nail : Engineered fi implant-grade Titanium Alloy (Ti-6Al-4V ELI), a ɛwɔ optimized anatomical curvature ne multi-planar locking nhyehyɛe ahorow ma rigid fixation ma complex shaft fractures.

  • Tibial Intramedullary nail : Wɔayɛ no ne progressive proximal dynamic locking options ne cannulated profile, a ɛhyɛ mu duru a wɔde soa ntɛm ne nnompe a ɛsa ntɛmntɛm ho nkuran.

  • Humeral Intramedullary nail : Aduru titiriw a ɛwɔ soro a ɛma ɛyɛ mmerɛw sɛ wɔbɛfa so ayɛ nea ɛnyɛ den pii, a ɛmma ntini a ɛyɛ mmerɛw no sɛe na ɛbɔ rotator cuff no ho ban.

  • Proximal Femoral Nail Antirotation - PFNA : Ɛwɔ helical blade nhyehyɛe a wɔayɛ no yiye ama ayarefo a wɔn mfe akɔ anim a wɔwɔ nnompe nhyehyɛe a ɛyɛ mmerɛw, a ɛhwɛ hu sɛ ɛko tia nea ɛkorɔn sen nea wɔatwa bere a wɔde trochanteric fracture fixation no asi hɔ.

4. Zimmer Biomet Holdings, Inc., a wɔyɛ adwuma wɔ hɔ no.

Zimmer Biomet de dijitaal akwahosan ho nhyehyɛe ahorow ne ntini ne nnompe a wɔde si hɔ a ɛyɛ fɛ bom, na ɛsom nkurow akɛse mu akwahosan nhyehyɛe atitiriw wɔ Bulgaria nyinaa.

• Nneɛma Titiriw: Digitals akwahosan ho kyerɛwtohɔ a ɛne ne ho hyia, nkwaa a wɔde besi ananmu, agumadi mu nnuru a wɔde yɛ nneɛma, ne nneɛma a wɔde hyɛ nipadua mu a ɛma obi ho dwiriw no.

• Core Portfolio: Natural Nail System no wɔ nipadua mu nkuruwankuruwa a wɔayɛ sɛ ɛbɛfata ayarefo nipadua ahorow ahorow wɔ Europa nnipa dodow nyinaa mu.

5. Smith & Nephew plc na wɔyɛ adwuma wɔ hɔ

Esiane sɛ Smith & Nephew a ɛwɔ UK no yɛ adwuma tẽẽ a ɛyɛ nnam ne nneɛma a wɔde kɔ amannɔne a ɛyɛ den wɔ Europa nyinaa nti, ɛkyɛn so wɔ akuru a wɔhwɛ a ɛkɔ akyiri ne ahodwiriw nhyehyɛe titiriw mu.

• Nneɛma Titiriw a Wɔde Yɛ: Kuru ho nhyehyɛe a ɛkɔ anim, mfiri a wɔde hwɛ ntini mu nhwehwɛmu, ne nnompe mu apirakuru ho mfiri.

• Core Portfolio: TRIGEN Interlocking Nail System no wɔ nneɛma soronko a wɔde wie wɔ soro a wɔayɛ no yiye ama akwaa a ɛwɔ fam ne asen a ɛpaapae a emu yɛ den ho dwuma.

6. B. Braun Melsungen A. G. (Asculap) a ɔyɛ ɔbarima a ɔyɛ ɔdefo.

B. Braun a ogyina hɔ ma Germany mfiridwuma a ɛkorɔn no hwɛ nnwumakuw ne nneɛma a wɔkyekyɛ ho nhyehyɛe a wotumi de ho to so kɛse so wɔ Europa Kesee Fam nyinaa, na ɛma Bulgaria ayaresabea mmeae nya ahodwiriw nhyehyɛe ahorow a ɛyɛ soronko a ɛtra hɔ kyɛ, a wɔayɛ no pɛpɛɛpɛ.

• Nneɛma Titiriw a Wɔde Yɛ: Infusion therapy nhyehyɛe, oprehyɛn nnwinnade, akyi berɛmo a wɔde hyɛ nipadua mu, ne structure trauma hardware.

• Core Portfolio: Targon Interlocking Nail System no ma locking pɛpɛɛpɛ a ɛkorɔn ma nnompe tenten femur ne tibia nhyehyɛe ahorow a wɔsan yɛ a ɛhwehwɛ.

7. Medtronic adwumayɛbea ahorow

Bere a ɛwɔ tumi kɛse wɔ pacemakers ne akyi berɛmo mfiri mu no, Medtronic structural osteo-division no di ahwehwɛde ahorow a ɛyɛ den a ɛfa multi-trauma fixation fixation ahwehwɛde ahorow ho wɔ ɔmantam Bulgaria akwahosan akuw mu.

• Nneɛma Titiriw a Wɔde Yɛ: Akyi berɛmo mu nneɛma, akwan a ɛkɔ akyiri a wɔde kyerɛ kwan, mfiri a wɔde yɛ ntini mu oprehyɛn, ne nneɛma titiriw a wɔde hyɛ nipadua mu a ɛma obi ho dwiriw no.

• Core Portfolio: Nnwinnade nhyehyɛe a ɛyɛ mmerɛw a wɔde abɔ amansan nyinaa a ɛka bom nhyehyɛe a ɛfata ma nnompe a wɔsan yɛ a ɛyɛ den kɛse.

8. Orthofix Aduruyɛ Inc.

Orthofix di mu wɔ mu ne akyi fixation nyansapɛ ahorow a wɔde ka bom mu, de abɔde a nkwa wom a wɔsan yɛ no foforo ho akwan soronko ma nnompe ho abenfo wɔ Bulgaria nyinaa.

• Nneɛma Titiriw a Wɔde Yɛ: Abɔnten so nneɛma a wɔde si hɔ, ayaresa a ɛkanyan nnompe nyin, ne nhyiam titiriw a wɔde ma akwaa a ɛwɔ ntini no mu.

• Core Portfolio: Mmofra ne mpanyimfo micro-nailing nhyehyɛe titiriw a wɔde wɔn adwene sii intertrochanteric anaa shaft nnompe mu sintɔ ahorow a emu yɛ den a wobedi so.

9. Acumed LLC a ɛwɔ hɔ

Acumed de n’adwene si nipadua mu nneɛma a wɔyɛ no pɛpɛɛpɛ so ma akisikuru a ɛwɔ atifi fam no, na ɛde nneɛma a ɛyɛ soronko koraa a animdefo nketewa a wɔyɛ akwaa a ɛwɔ soro wɔ Bulgaria ayaresabea atitiriw no ani gye ho ma.

• Nneɛma Titiriw a Wɔde Yɛ: Anatomical Locking plates , osteotomy nhyehyɛe titiriw, ne nnompe mu abaa a wɔde wɔn ani asi so wɔ atifi fam.

• Core Portfolio: Humeral intramedullary nnadewa a ɛwɔ fam ne nsateaa abaa a wɔayɛ sɛ wɔde bɛtew ntini a ɛyɛ mmerɛw a ɛbɛbɔ no so.

10. Globus Aduruyɛ, Inc.

Wɔ ne nkabom a ɛkorɔn a ɛne NuVasive nnansa yi akyi no, Globus Medical atrɛw ne ahodwiriw ne adansi anammɔn mu ntɛmntɛm wɔ ayaresabea nkitahodi ahorow a ɛwɔ Europa Mfinimfini ne Apuei fam no nyinaa mu.

• Nneɛma Titiriw a Wɔde Yɛ: Ntini ne nnompe ano aduru a edi mũ, akyi berɛmo mu nneɛma a ɛkɔ anim, ne robɔt a wɔde boa ma wɔde fa adwenemhaw so.

• Core Portfolio: CAPTIVATE Trauma System, a ɛwɔ nnwinnade a wɔayɛ no mmerɛw a wɔayɛ sɛnea ɛbɛyɛ a asen ne asen no bɛka abom yiye.

11. Wright Aduruyɛ Kuw NV (Adwumakuw bi a Wɔyɛ Stryker) .

Wɔyɛ adwuma wɔ Stryker ahodwiriw abusua no mu, Wright Medical agyapade a ɛwɔ fam ne nan ne nan ase hardware da so ara yɛ nea wɔpaw sen biara ma nkwaa a wɔde frafra ne nteɛso a ɛyɛ den wɔ Bulgaria.

• Nneɛma Titiriw a Wɔde Yɛ: Nnompe a wɔde hyɛ nipadua no atifi, wɔde si ananmu nyinaa, ne nnompe a wɔde hyɛ nipadua no mu a ɛkɔ akyiri.

• Core Portfolio: Akyi nan ne ankle fusion abaa titiriw a wɔayɛ ama ntini mu oprehyɛn a ɛyɛ den.

12. Aap Fa AG hyɛ nipadua mu

Aap Implantate yɛ adwumakuw bi a ɛwɔ Germany a wogye no tom sɛ wɔde dwetɛ a wɔde kata so ne mfiridwuma a wɔde kata ɔyare mmoawa ano a wɔayɛ sɛ wɔde bɛtew ɔyare mmoawa a ɛba bere a wɔde ahyɛ nipadua mu no so aba.

• Nneɛma Titiriw: LOQTEQ Locking plate abusua no ne dwetɛ a wɔde akata so a ɛko tia ɔyare mmoawa a wɔde hyɛ nipadua mu.

• Core Portfolio: Titanium interlocking systems a wɔde cannulated ne solid ayɛ a wɔasisi sɛnea ɛbɛyɛ a wɔbɛtew oprehyɛn akyi nsɛnnennen so bere a wɔde nnompe tenten reyɛ adwuma no.

13. CarboFix Nnompe Ho Nnuruyɛfo Ltd.

CarboFix yɛ ɔkwampaefo wɔ carbon-fiber mfiridwuma mu, na ɛde botae titiriw a ɛkorɔn ma wɔ nnompe oprehyɛn a ɛfa oncology ho wɔ Bulgaria kokoram akuw titiriw no nyinaa mu.

• Nneɛma Titiriw a Wɔde Yɛ: Polymer mprɛte a wɔde carbon fiber ahyɛ mu den, carbon nnade a wɔde yɛ adwuma, ne radiolucent trauma implants.

• Core Portfolio: Piccolo Composite Nails, a ɛma kwan ma wɔyɛ mfonini a emu da hɔ, a artifact nnim bere a wɔredi oncological akyi ne radiation therapy a wɔde wɔn ani asi so no.

14. MicroPort Nyansahu Adwumakuw

MicroPort de mfiridwuma mu nhyehyɛe a ɛtrɛw di dwuma, kyekyɛ koma ne ntini ne nnompe ho akwan a ɛho ka sua, a ɛdɔɔso pii wɔ Europa Apuei Fam akwan horow so de di ayaresabea sikasɛm nhyehyɛe a emu yɛ den ho dwuma.

• Nneɛma Titiriw a Wɔde Yɛ: Koma ne ntini mu stent a ɛnyɛ den pii, nkwaa a wɔde yɛ nipadua no, ne mfiri a wɔde siw apirakuru ano koraa.

• Core Portfolio: Interlocking intramedullary nnadewa nhyehyɛe ahorow a wɔayɛ no sɛnea ɛbɛyɛ a wobetumi ayɛ no mpɛn pii, na ɛyɛ mmerɛw sɛ wɔde bɛhyɛ mu.

15. Wego Ortho (Weigao Kuw) .

Wego Ortho yɛ Asia nnuruyɛ adwumakuw akɛse no mu biako, na ɛde nnuru a wɔde hyɛ nipadua mu a ɛyɛ aduruyɛ mu a wotumi de ho to so kɛse a ɛne Europa ayaresabea ahwehwɛde ahorow a emu yɛ den hyia ma.

• Nneɛma Titiriw a Wɔde Yɛ: Mfiri a wɔde hyɛ akyi berɛmo mu, mprɛte a wɔde hyɛ nipadua no mu, nkwaa a wɔde yɛ nipadua no, ne nneɛma a wɔde yɛ oprehyɛn a ɛnyɛ ɔyare mmoawa.

• Core Portfolio: Titanium nnadewa a ɛyɛ den a ɛka bom a wɔayɛ ama ɔman no mu tender apam a ɛho ka sua ne tender apam a ɛyɛ kɛse wɔ Bulgaria a wɔaboaboa ano kɛse.

── ADWUMA A WƆYƐ YIYE MATRIX ──

Nsɛm a Wɔtaa Bisa (FAQ) .

Q1: So nnadewa a ɛwɔ medullary mu a wɔhwehwɛ ma Bulgaria gua no hia CE Agyiraehyɛde wɔ EU MDR ase?

Yiw, koraa. Esiane sɛ Bulgaria yɛ Europa Aman Nkabom no muni koraa nti, ɛsɛ sɛ nnadewa a ɛwɔ ntini mu a wɔtɔn wɔ ɔman no mu nyinaa nya CE Agyiraehyɛde a ɛfata wɔ Aduruyɛ Mfiri Mmara (MDR 2017/745) ase . Class IIb ne Class III Nnompe a wɔde hyɛ nnompe mu yɛ mfiridwuma mu nhwehwɛmu a emu yɛ den ne ayaresabea nhwehwɛmu. Ɛsɛ sɛ adetɔ ho adwumayɛfoɔ hwɛ sɛ amannɔne adwinnadeɛ biara, te sɛ CZMEDITECH , de Mpaemuka a ɛfa Nhyiamu a ɛyɛ adwuma ho ma na wɔakyerɛw no yie wɔ EUDAMED database no mu.

Q2: Dɛn ne ahwehwɛde ahorow a wɔde kyerɛw wɔn din wɔ Bulgaria Nnuru Dwumadibea (BDA) no mu?

Wɔ Bulgaria Mmara a Ɛfa Aduruyɛ Mfiri Ho ( Закон за медицинските изделия ) ase no, mfiri a ɛwɔ CE agyiraehyɛde a ɛfata dedaw a efi EU Kuw a Wɔabɔ no Amane no hɔ no nhia sɛ wɔde wɔn din bɛhyɛ mu a ɛyɛ soronko, a ɛde ne ho denam BDA (Bulgaria Nnuru Dwumadibea / Изпълнителна) so агенция по лекарствата - ИАЛ) . Nanso, sɛ nea ɔyɛ no wɔ Europa Sikasɛm Mpɔtam (EEA) akyi a, ɛsɛ sɛ wɔpaw Ɔnanmusifo a Wɔama No Tumi (AR) wɔ EU mu. Ɛsɛ sɛ Bulgaria a ɔkyekyɛ nneɛma a ɛwɔ mpɔtam hɔ no nso kyerɛw wɔn aguadi dwumadi ahorow no din na ɔde mfiridwuma ho nkrataa sie wɔ mpɔtam hɔ anyɛ yiye koraa no mfe anum sɛ ɛba sɛ BDA bɛhwɛ mu a.

Q3: Dɛn nti na Helical Blade nhyehyɛe (te sɛ PFNA) yɛ ade titiriw ma NHOK sikasɛm nhyehyɛe a wɔkyekyɛ wɔ Bulgaria?

Bulgaria hyia nnipa dodow ho nsɛnnennen a ɛda nsow esiane nnipa a wɔn mfe akɔ anim nti, na ɛde nkwakoraa ne mmerewa asen a ɛpaapae kɛse ba. Amanneɛ kwan so lag screws wɔ huammɔdi dodow a ɛkorɔn denam mfiri 'cut-out' wɔ osteoporotic dompe mu. Sɛ wonya ano aduru a ɛkɔ akyiri te sɛ CZMEDITECH ’s PFNA—baabi a helical blade mia dompe a atwa ho ahyia no mmom sen sɛ ɛbɛtu afi mu—ma ɛkyinkyini no gyina pintinn kɛse. Eyi brɛ oprehyɛn akyi nsakrae a ɛho ka yɛ den ne ayarefo nsɛnnennen ase, a ɛho hia kɛse wɔ Ɔman Akwahosan Insurance Foto ( НЗОК ) sikasɛm mu anohyeto a emu yɛ den no ase.

Q4: Ɔkwan bɛn so na Bulgaria Ɔmanfo Adetɔ Mmara (ZOP) no ka IM nnadewa ho aguadi nhyehyɛe no?

Wɔ ЗОП (Закон за обществените поръчки) ase no , ɔman ayaresabea nkitahodi ahorow de mfe pii apam a wɔde ma a egyina 'tender a mfaso wɔ so sen biara wɔ sikasɛm mu so ma.' Saa kwan yi de Value-Based Procurement criteria ka bom kɛse, de nkontabuo mu duru kɛseɛ ma mfiridwuma sodi (te sɛ Grade 5 Titanium Alloy Ti-6Al-4V ELI nneɛma adansedi, nipadua mu agyan a ɛyɛ pɛpɛɛpɛ, ne nnwinnade kit ergonomics) ka bo ho. Nnwumayɛfoɔ a wɔde nneɛma a wɔyɛ a akansiɛ kɛseɛ wom ne mmara mu ahobanbɔ ma (te sɛ CZMEDITECH ) wɔ gyinabea pa paa sɛ wɔbɛdi nkonim wɔ saa ɔmanfoɔ a wɔde bɛto gua nhyehyɛeɛ yi mu.

Q5: Kasa bɛn mu na ɛsɛ sɛ wɔde nneɛma ho nsɛm ma wɔ Bulgaria ayaresabea ahorow mu?

Sɛnea BDA mmara kyerɛ no, Akwankyerɛ a Wɔde Di Dwuma (IFU) nyinaa ma wɔ ɛsɛ sɛ wɔde nsɛm a ɛfa ayarefo anim, nkyerɛwde, ne Bulgaria kasa mu . Bere a nnompe ho dwumadibea ahorow taa gye mfiridwuma mu oprehyɛn ho akwankyerɛ ahorow tom wɔ Borɔfo kasa mu no, tender board ahorow hyɛ mpɔtam hɔ kasa nkyerɛase so denneennen ma gyinapɛn a wɔde kyerɛw nsɛm ne sterilization protocols na ama wɔakura ahyehyɛde ahorow no ahobammɔ gyinapɛn ahorow mu.

Q6: So Bulgaria ayaresabea akuw betumi anya mfaso afi wɔn trauma procurement lines a wɔbɛhyɛ mu den no mu?

Yiw, nkabom yɛ ɔkwan a etu mpɔn kɛse a wɔfa so siw adansi ho ka ano. Ɛdenam gyinapɛn a wɔde bɛyɛ trauma procurement ne adwinnan hokafo biako te sɛ CZMEDITECH , ayaresabea akuw anaa ɔmantam akwahosan asoɛe ahorow betumi ayɛ nkitahodi wɔ dodow a wɔbɛtɔ ho nsɛm ho. Eyi ma wotumi de Femoral Nails, Tibial Nails, anatomical Locking plates , ne Aduruyɛ anyinam ahoɔden nnwinnade hyɛ bere koro mu. Saa kwan yi brɛ po so hyɛn ne amanne kwan so adwumayɛfo ntam ntawntawdi nyinaa ase, ɛtew adekoradan akyi di ho ka so, na ɛde nnwinnade nhyehyɛe a wɔahyɛ da ayɛ wɔ agoprama ahorow nyinaa so si hɔ.

Awie

Bere a Europa Atɔe Fam ne Amerika Atifi fam agyapade a wɔde di dwuma wɔ amanne kwan so no kɔ so kura anammɔn a ɛda nsow wɔ Bulgaria ankorankoro ayaresabea ahorow mu no, sikasɛm mu anohyeto ahorow a ɛwɔ ɔmanfo akwahosan ho sikasɛm nhyehyɛe ( НЗОК ) mu ne akansi su a ɛwɔ ɔmanfo sika a wɔde ma ( ЗОП ) mu no ama wɔadan wɔn ho denneennen akɔ wɔn a wɔyɛ nneɛma a wɔyɛ ntɛmntɛm na wɔwɔ wiase nyinaa adansedi krataa no so. Wɔn a wɔde mmoa ma no te sɛ CZMEDITECH de boɔ ho nyansahyɛ a ɛyɛ den kɛseɛ ma Bulgaria nnɛyi ahodwiriw akuo no denam Europa aduruyɛ ho adansedie a ɛyɛ fɛ ( CE / ISO ) ne nneɛma a wɔde hyɛ nipadua mu a wɔde yɛ nneɛma a wɔayɛ no yie paa a ɛne no hyia.