Top 15 Clou intramédullaire Dilanbaga minnu bɛ Pɔritigali (2026 sannifeere gafe)

Daminɛ kuma

Furakɛminɛnw sanniko siratigɛ la Pɔritigali kolotugudaw la, o bɛ ka wuli teliya la u jɔcogo la. Kɛnɛya minisiriso ( Ministério da Saúde ) ka musakaw kunbɛnni yamaruya gɛlɛnw fɛ ani bɔnɛ hakɛ caman minnu bɛ mara sigida kɛnɛyasow fɛ ( Unidades Locais de Saúde - ULS ) jamana ka kɛnɛyako baarada ( Serviço Nacional de Saúde - SNS ) ka fanga kɔrɔ — ka fara dɔgɔtɔrɔso jɛkulu kɛrɛnkɛrɛnnenw ɲɛmɔgɔw kan i n’a fɔ Luz Saúde, CUF, ani Lusíadas Saúde—dɔgɔtɔrɔso sannifeere tɔnw ka fɛnw bila jɔyɔrɔ fɔlɔ la minnu bɛ balansi ɲuman di kɛnɛyaso nafa, sariyaw lakanani, ani baarakɛnafolo kofɔlenw na.

Ni aw bɛ kolo janw karilenw ɲɛnabɔ, ka ɲɛgɛnɛsira kɔnɔ (IM) jɛɲɔgɔn ɲuman sugandi, o nafa ka bon kosɛbɛ walasa ka opereli kɔfɛ gɛlɛyaw dɔgɔya ani ka sigida musakaw ɲɛnabɔ Concursos Públicos (Forobaciyɛnw) ka hukumu kɔnɔ ani sannifeere ɲɛmɔgɔso cɛmancɛ la, n’o ye SPMS ( Serviços Partilhados do Ministério da Saúde ) ye. Nin gafe in bɛ Pɔritigali Clou intramédullaire fɛn dilannikɛla ŋana 15 jira, k’a sinsin u ka bolofara fɔlɔw kan, sugu tɔgɔladon, ani fɛɛrɛ jɔnjɔnw kan walasa ka biyomedikɛli injiniyɛriw, kolotugudaw operelikɛlaw, ani fɛnw dilancogo ɲɛmɔgɔw dɛmɛ u ka se ka latigɛw kɛ minnu sinsinnen bɛ kunnafonidilanw kan.

Fɛɛrɛko yiriwali: Clou intramédullaire dilancogo kɛrɛnkɛrɛnnenw faamuyali bi bɔnɛ sɔrɔli la

Dɔgɔtɔrɔso tender jateminɛ bɛɛ lajɛlen na kɛnɛyaso ɲɛmɔgɔbaw kɔnɔ, kolotugudaw ka joginda sanni bɛ a ɲini ka faamuyali jugu sɔrɔ fɛɛrɛko siratigɛ la, min bɛ kɛ fɛnw doncogo mekanikiniw kan. Nɛgɛ minnu bɛ kɛ wuluwulu kɔnɔ, olu tɛ nɛgɛberew ye minnu bɛ kɛ fɛn bɛɛ ye tuguni; bi opereli bɛ biyomekaniki dilancogo kɛrɛnkɛrɛnnenw de wajibiya minnu bɛ bɛn kari cogoya kɛrɛnkɛrɛnnen ma ani banabagatɔ ka bana cogoya ma.

Walasa ka dɔgɔtɔrɔso ɲɛmɔgɔw ni opereli jɛkuluw dɛmɛ ka joginda sɔrɔcogo nɔgɔya, a nafa ka bon kosɛbɛ ka Clous intramédullaires suguya kɛrɛnkɛrɛnnen fɔlɔw faamuya minnu bɛ bi kolotugudaw ɲɛnajɛw fanga la:

1. Interlocking Clous intramédullaires (Sɔli ni kanula) .

Sugandili min bɛ kɛ wuluw dilanni gɛlɛnw ni nɛgɛw dilanni na, o bɛ nɔba bila opereli baara kɛcogo la ani kolo kɛnɛyali biologiki la.

• Kanula Clous intramédullaires  : Nin nɛgɛ ninnu cɛmancɛ bɛ kɛ ni dingɛ ye, o b’a to u bɛ se ka don ɲɛminɛlan dɔ kan. O kɛcogo in bɛ kɛ sababu ye operelikɛlaw ka se ka reamed insertion kɛ, o bɛ medullary canal bonya, ka kɛ sababu ye ka nɛgɛso belebeleba ni barika sɔrɔ, ani ka sigida kolotugudaw yɔrɔw bila ka ɲɛsin kariyɔrɔ ma walasa ka kɛnɛya teliya.

• Solid Clous intramédullaires : A bɛ kɛ fɔlɔ fɛɛrɛw la minnu ma sɔgɔ, a ka ca a la, wulu gɛlɛnw bɛ sugandi da wulilen jugumanba walima joginda caman na walasa ka tulumafɛnw bɔli farati dɔgɔya ani ka kɔnɔbara basigilen joli sɔrɔli dɔgɔya.

2. Senkɔni-nɛgɛw & Senkɔniw kɛrɛfɛ-yɔrɔw

Ni kariw bɛ kɛ senkɔni dakun kɛrɛfɛ (kɔkolo yɔrɔ), wulu minnu bɛ ɲɔgɔn siri cogo la, olu tɛ se ka kɛ. Kungolodimi kɛrɛnkɛrɛnnenw de ka kan ka kɛ walasa ka farikolo doni jugumanw kunbɛn.

• Reconstruction Locking Configurations : Nin dilan ninnu bɛ kɛ ni dingɛ kɛrɛnkɛrɛnnenw ye minnu bɛ tugu ɲɔgɔn kɔ, minnu bɛ kɛ ni degere 130 fo 135 ɲɔgɔn ye, o b’a to lag screws gɛlɛnw bɛ tɛmɛ nɛgɛ fɛ ka taa senkɔni kun na, ka senkɔni kunkolo karilenw siri subtrochanteric walima ipsilateral.

• Anti-Rotation Helical Blade Systems : A bɛ kɛ ka caya mɔgɔkɔrɔbaw ka kɔkolo karilenw na, o fɛɛrɛ ninnu bɛ laadala lag screws bila compression blade nɔ na. Nin dilan in bɛ kolo kansɛri lamini degun sanni k’a bɔ, o bɛ dɔ bɔ kosɛbɛ 'tigɛ' donli la koloci kolo la.

3. Kɔnɔnatumu minnu kolo janw bɛ kɔsegin ni ɲɛfɛla la

Ka kɛɲɛ ni kari yɔrɔ ni farikolo yɔrɔ nɔgɔlenw dafalen ye, operelikɛlaw ka kan ka dondaw sugandi minnu bɛ ɲɔgɔn kɛrɛfɛ walasa ka wulu don.

• Anterograde Sourcing : Fɛn minnu bɛ don a kɔnɔ ka bɔ a kɛrɛfɛla la (misali la, ka don senkɔni na walasa ka senkɔni kari). O bɛ kɛ sababu ye ka wulu biri tigitigi walasa ka bɛn farikolo yɔrɔw kurulenw ma minnu bɛ sɔrɔ u yɛrɛ la.

• Retrograde Sourcing : Fɛn minnu bɛ don a kɔnɔ ka bɔ yɔrɔ jan na (misali la, u bɛ don gɛnɛgɛnɛ kolotuguda sanfɛ dɔrɔn). Senkɔniw kɛrɛnkɛrɛnnen minnu bɛ kɔfɛ, olu bɛ ni yɔrɔjan datugucogo kɛrɛnkɛrɛnnenw ye walasa ka yɔrɔjan kunsigi sabanan karilenw lakana minnu ka gɛlɛn.

Duniya Industry Giants & Leading Brands

1. Stryker ka tɔnba

A ye ɲɛmɔgɔba ye Pɔritigali ka rezow kɛrɛnkɛrɛnnenw na minnu ka bon kosɛbɛ ani inivɛrisite dɔgɔtɔrɔsow la minnu ka ca, Ameriki sigida la, Stryker bɛ bonya kosɛbɛ a ka ɛntɛrinɛti injiniyɛri tigitigi n’a ka jago dɛmɛ barikama kosɔn.

• Fɛn fɔlɔ minnu bɛ kɛ: Jogindaw caman cili, robo dɛmɛnanw (Mako), farikoloɲɛnajɛ minɛnw, ani joginda labɛnni fɛɛrɛ kɔrɔw.

• Portfolio koloma : Gamma4 Trochanteric Nail System ani T2 Alpha Interlocking Nail System bɛ masin sabatili ɲɛtaa ni minɛnw labɛncogo laɲinitaw di.

2. DePuy Synthes (Johnson ni Johnson ka baarakɛɲɔgɔnya) .

A jɔyɔrɔ min sinsinnen don kosɛbɛ foroba (SNS) dɔgɔtɔrɔsow ni dankan dɔgɔtɔrɔsow bɛɛ la Pɔritigali, DePuy Synthes bɛ baara kɛ ni san tan caman ye kɛnɛyaso ɲininiw na minnu bɛ dɛmɛ sɔrɔ AO Foundation fɛ.

• Fɛn fɔlɔ minnu bɛ kɛ : Jogindaw bɛɛ lajɛlen, kolotugudaw labɛnni furaw, ɲɛda ni ɲɛdawolo minɛnw, ani kɔkolo biyomatɛriw.

• Core Portfolio: Expert Nail System ani TFNA (Trochanteric Fixation Nail Advanced) bɛ baara kɛ ni nɛgɛ furakɛli minnu ye u yɛrɛ ta ye, minnu bɛ ɲɛ ka ɲɛsin trochanteric ni kolo janw karilen gɛlɛnw ma.

3. CZMEDITECH

I n’a fɔ fangatigi min lakodɔnnen don diɲɛ kɔnɔ kolotugudaw furakɛli minɛnw na, CZMEDITECH ye sɔrɔko sennasanbara dɔ sigi senkan min bɛ ka bonya Erɔpu Saheliyanfan sugu la, Pɔritigali fana sen bɛ o la. A tɔgɔ bɔra kosɛbɛ ka danfara don Alemaɲi ka fɛn dilanni nafamaba ni fɛn dilanni nafama cɛ, o baarakɛda bɛ bɔnɛko caman dilan min bɛ diɲɛ furakɛli yamaruya gɛlɛnw mara—o la ISO 13485, CE seereyaw bɛ o la—o b’a kɛ jɛɲɔgɔn ɲuman ye Hospitais Universitários ni ULS rezow belebelebaw bolo minnu b’a ɲini ka fɛn dilanni hakɛ caman ɲɛnabɔ sannifeere kɛli Erɔpu foroba sannifeere sariyaw kɔnɔ.

CZMEDITECH Fɛnɲɛnɛmafagalan fɔlɔw

• Orthopedic Trauma Systems: Ɲɛnabɔli ɲɛtaa Clous intramédullaires , Farikoloɲɛnajɛ Locking platew & Vis, ani Kɛnɛma Fixation Systems (Kɛnɛyako Fixation Systems).

• Kɔkolo sirili furaw : Kɔnɔbara ɲɛfɛla/kɔfɛla & barajuru, farikolo ni ɲɔgɔn cɛ fusion cages, ani kɔkolo sirili berew.

• Cranio-Maxillofacial ( CMF ) Implants : Titanium Plates ultra-low profile ani File Sistɛmu minnu bɛ ɲɛda labɛn kokura.

• Opereli fanga baarakɛminɛnw ni u dɛmɛnanw: Perceuse orthopédique s minnu bɛ baara kɛ kosɛbɛ, Sɔgɔlan minnu bɛ wuli, ani sterilize minɛnw minɛn minnu bɛ bɛn ɲɔgɔn ma.

• Customized OEM/ODM Services : Furakɛcogo min bɛ kɛ laban na ka taa a laban na min bɛ bɛn diɲɛ dɔgɔtɔrɔsow ka sariyaw ma.

• Core IM Nail Portfolio & Jɛɲɔgɔnyaw:

  • Senkɔni Clou intramédullaire : A dilannen don ni Titanium Alloy (Ti-6Al-4V ELI) ye min bɛ se ka don a kɔnɔ, a bɛ ni farikolo kurulen ɲuman ye ani a datugucogo caman ye walasa ka jɔli gɛlɛn di jiribolo karilenw ma minnu ka gɛlɛn.

  • Tibial Clou intramédullaire : A dilannen don ni progressive proximal dynamic locking options ye ani profil cannulé, o bɛ girinya ta joona ani kolo kɛnɛyali teliya la.

  • Humeral Clou intramédullaire : Sanfɛla fura kɛrɛnkɛrɛnnen min bɛ fɛɛrɛ nɔgɔya min tɛ fɛn caman kɛ, ka farikolo yɔrɔ nɔgɔlenw tiɲɛni dɔgɔya ani ka rotator cuff lakana.

  • Proximal Femoral Nail Antirotation - PFNA : A bɛ ni helical blade system ye min ka ɲi banabagatɔ kɔrɔbaw ma minnu kolociw bɛ kolociw la, o bɛ a to u ka se ka tigɛcogo ɲuman sabati trochanteric fracture fixation waati.

4. Zimmer Biomet Holdings, Inc. ye baarakɛyɔrɔ ye min bɛ wele ko Zimmer Biomet Holdings.

Zimmer Biomet bɛ kɛnɛyako nizɛri siraw fara ɲɔgɔn kan ni farikolo ni kolotugudaw labɛnni fɛɛrɛ ɲumanw ye, ka baara kɛ dugubaw kɔnɔ kɛnɛyasobaw ye Pɔritigali jamana bɛɛ kɔnɔ.

• Fɛn fɔlɔw: Kɛnɛya jateminɛ nizɛri minnu bɛ bɛn ɲɔgɔn ma, kolotugudaw caman cili, farikoloɲɛnajɛ furakɛli minɛnw, ani joginda doncogo.

• Core Portfolio: Natural Nail System bɛ farikolo yɔrɔw kurulenw jira minnu dabɔra ka bɛn banabagatɔw cogoya suguya caman ma Erɔpu Tlebi jamanaw ka jamanaden hakɛw bɛɛ la.

5. Smith & Nephew ka baarakɛyɔrɔ

Ni baara tilennenw bɛ baara la ani ni fɛnw ladonni yɔrɔ barikamaw ye Iberia jamana bɛɛ kɔnɔ, Angletɛri sigida Smith & Nephew ka fisa ni joginda ladonni ɲɛtaa ye ani joginda kɛrɛnkɛrɛnnenw na.

• Fɛn fɔlɔ minnu bɛ kɛ: Jogindaw furakɛcogo kɔrɔlenw, joli-sira-funu-yɔrɔ-ko-minɛnw, ani kolotugudaw ka joginda-minɛnw.

• Core Portfolio: TRIGEN Interlocking Nail System bɛ ni yɔrɔ kɛrɛnkɛrɛnnenw ye minnu bɛ kɛ ka ɲɛ walasa ka senkɔniw ni senkɔniw karilen jugumanw kunbɛn.

6. B. Braun Melsungen A. G. (Asculap) ye baara kɛ ni a ye.

A bɛ Alemaɲi injiniyɛri kuncɛyɔrɔ jira ni tɔnba ni fɛnw ladonni sennasanbaraba ye Pɔritigali (a sigiyɔrɔba bɛ Queluz DE Baixo), B. Braun bɛ Pɔritigali dɔgɔtɔrɔsow di ni bɔnɛko cogoyaw ye minnu bɛ mɛn cogo kɛrɛnkɛrɛnnen na, minnu dilannen don ni tigitigi ye.

• Fɛn fɔlɔ minnu bɛ kɛ: Pikirijikɛlanw, opereli minɛnw, kɔkolo doncogo, ani structural trauma hardware.

• Core Portfolio: Targon Interlocking Nail System bɛ da tugucogo ɲumanba di walasa ka kolo jan senkɔniw ni senkɔniw jɔcogo kura ɲini.

7. Medtronic ka baarakɛyɔrɔ

Hali n’a fanga ka bon kosɛbɛ pacemakers ni kɔkolo minɛnw na, Medtronic ka structural osteo-division bɛ baara kɛ ni fɛn gɛlɛnw ye minnu bɛ se ka kɛ sababu ye ka trauma fixation multi-trauma fixation wajibiyalenw ɲɛnabɔ marabolow kɔnɔ Pɔritigali kɛnɛyajɛkuluw kɔnɔ.

• Fɛn fɔlɔ minnu bɛ kɛ: Kɔkolola minɛnw, taamayɔrɔ kɔrɔlenw, hakililabaarakɛminɛnw, ani joginda kɛrɛnkɛrɛnnenw doncogo.

• Core Portfolio : Minɛnw dilanni minnu bɛ se ka wuli ka bɔ ɲɔgɔn na, olu faralen don ɲɔgɔn kan ni diɲɛ bɛɛ ka ɲɔgɔn cɛ cogoyaw ye minnu bɛnnen don kolotugudaw jɔcogo gɛlɛnba ma.

8. Orthofix Dɔgɔtɔrɔso Inc.

Orthofix ka fisa ni kɔnɔna ni kɛnɛma fixation philosophies faralen ye ɲɔgɔn kan, a bɛ biologique remodeling sugandili kɛrɛnkɛrɛnnenw di kolotugudaw kɛrɛnkɛrɛnnenw ma Pɔritigali jamana bɛɛ kɔnɔ.

• Fɛn fɔlɔw: Kɛnɛma sirilanw, kolo falenni furakɛli fɛɛrɛw, ani senkɔniw janya lajɛ kɛrɛnkɛrɛnnenw.

• Core Portfolio : Denmisɛnw ni balikuw ka mikro-nailing systems kɛrɛnkɛrɛnnenw minnu sinsinnen bɛ intertrochanteric walima shaft kolo gɛlɛya jugumanw ɲɛnabɔli kan.

9. Acumed LLC ka baarakɛyɔrɔ

Acumed bɛ sinsin farikolo yɔrɔw tiɲɛni kan sanfɛla karilenw na, ka minɛn kɛrɛnkɛrɛnnenw di minnu ka di kamankunw ni sanfɛlanw kɛrɛnkɛrɛnnenw ye Pɔritigali dɔgɔtɔrɔso kɛrɛnkɛrɛnnenw na.

• Fɛn fɔlɔ minnu bɛ kɛ : farikololabɔ Locking platew , koloci kɛrɛnkɛrɛnnenw, ani sanfɛla-kɔnɔna-kɔnɔ-berew laɲinitaw.

• Core Portfolio: Humeral intramedullary nails ni bolokɔni ɲɛfɛla bere minnu bɛ duguma, olu dilannen don walasa ka farikolo yɔrɔ nɔgɔlenw sɔgɔli nɔgɔya.

10. Globus Medical, Inc. ka baarakɛyɔrɔ.

A ka jɛɲɔgɔnyaba kɔfɛ ni NuVasive ye kɔsa in na, Globus Medical y’a ka bɔnɛ ni jɔli senna teliya la bonya kɛnɛyako kɛrɛnkɛrɛnnenw ka rezow kɔnɔ Erɔpu Saheliyanfan na.

• Fɛn fɔlɔw: Farikolo ni kolotugudaw furakɛcogo bɛɛ lajɛlen, kɔkolo fɛnɲɛnamafagalan kɔrɔlenw, ani robo dɛmɛni ka joginda ɲɛminɛcogo.

• Core Portfolio: CAPTIVATE Trauma System, min bɛ ni minɛnw ye minnu dilannen don ka ɲɛ, minnu dabɔra senkɔni ni senkɔniw ka ɲɔgɔn cɛ ka ɲɛ.

11. Wright Dɔgɔtɔrɔso kulu NV (A Stryker Company) .

Baara kɛli Stryker ka joginda denbaya kɔnɔ, Wright Medical ka senkɔniw ni senkɔniw fɛnɲɛnamafagalan kɔrɔw tora sugandili sanfɛla ye kolotugudaw jɔli gɛlɛnw ni u farali la Pɔritigali.

• Fɛn fɔlɔ minnu bɛ kɛ: Sanfɛla senkɔniw doncogo, senkɔniw bɛɛ cili, ani kolotugudaw sɔgɔcogo kɔrɔlenw.

• Core Portfolio: Senkɔniw ni senkɔniw fusili bere kɛrɛnkɛrɛnnenw minnu bɛ segin kɔfɛ, minnu dilannen don joli-sira-funu opereli gɛlɛnw kama.

12. Aap ka AG don a kɔnɔ

Aap Implantate ye Alimanjamana ka fɛn dilannikɛla ye min lakodɔnnen don a ka warijɛ dacogo kura ni banakisɛfagalanw dabɔli fɛɛrɛ kuraw labɛnni na minnu dabɔra walasa ka banakisɛw dɔgɔya minnu bɛ sɔrɔ fɛnw doncogo fɛ.

• Fɛn fɔlɔ minnu bɛ kɛ : LOQTEQ Locking plate denbaya ani warijɛ dabɔlen banakisɛfagalanw ka joginda la.

• Core Portfolio : Titanium interlocking systems cannulated ani solide minnu jɔra walasa ka opereli kɔfɛ gɛlɛyaw dɔgɔya kolo janw kɛtuma na.

13. CarboFix Orthopedics Ltd. ka baarakɛyɔrɔ.

CarboFix ye ɲɛmɔgɔ ye karɔbɔni-fibre fɛɛrɛbɔ la, a bɛ nafa jiracogo kɛrɛnkɛrɛnnenba di kansɛri furakɛli ma min bɛ tali kɛ kolotugudaw la Pɔritigali kansɛri furakɛli yɔrɔ kɛrɛnkɛrɛnnenw bɛɛ kɔnɔ.

• Fɛn fɔlɔw: Polimɛri platiw minnu barika ka bon ni fibre carbone ye, karɔbɔli nɛgɛw jɔcogo la, ani trauma implants radiolucentes.

• Core Portfolio : Piccolo Composite Nails, o bɛ sira di ja jɛlenw ma, minnu tɛ fɛn dilannenw ye, kansɛribana tuguni ni fiɲɛ furakɛli laɲini waatiw la.

14. MicroPort dɔnniya tɔnba

MicroPort bɛ baara kɛ ni izini infɔrɔmasikoba ye, a bɛ dusukun ni jolisiraw ni kolotugudaw sugandicogo caman tilatila Erɔpu Saheliyanfan siraw kan, minnu musaka ka dɔgɔ, minnu hakɛ ka ca, walasa ka dɔgɔtɔrɔsow ka baarakɛnafolo dantigɛli gɛlɛnw dafa.

• Fura fɔlɔw: Dusukun ni jolisiraw ka stent minnu tɛ fɛn caman kɛ, kolotugudaw, ani joginda labɛnni minɛn dafalenw.

• Core Portfolio : Nail systems intramedullaires interlocking minnu dilannen don walasa ka segin-ka-bɔnye fɛɛrɛw kɛ, minnu bɛ se ka kɛ ka ɲɛ.

15. Wego Ortho (Weigao kulu) .

Wego Ortho ye Azi furakɛlitɔnba dɔ ye, a bɛ furakɛli suguya dɔw lase mɔgɔ ma minnu bɛ se ka da u kan kosɛbɛ, minnu bɛ Erɔpu dɔgɔtɔrɔsow ka ɲinini gɛlɛnw dafa.

• Fɛn fɔlɔ minnu bɛ kɛ: Kɔkolo sirili minɛnw, structural trauma plates, kolotugudaw, ani opereli fɛnw sterili.

• Core Portfolio : Titaniyɔmu nɛgɛso minnu bɛ ɲɔgɔn siri minnu bɛ mɛn, minnu dilannen don foroba marabolow ka tenderi bɛnkansɛbɛnw kama minnu musaka ka dɔgɔ Pɔritigali jamana na.

── FƐN SƆRƆLI MATRIX ──

Ɲininkali minnu bɛ kɛ tuma caman na (FAQ) .

J1: Yala wuluwulu minnu ka kan ka kɛ Pɔritigali sugu la, olu mago bɛ CE taamasiyɛn na EU MDR kɔnɔ wa?

Ɔwɔ, tiɲɛ yɛrɛ la. Erɔpu furakɛli minɛnw sariyasun (MDR 2017/745) waleyali dafalen kɔfɛ, wuluwuluw bɛɛ minnu bɛ jago kɛ Pɔritigali jamana na, olu bɛɛ ka kan ka kɛ ni taamasiyɛn ye min bɛ se ka kɛ CE ye MDR ka laadilikanw kɔnɔ { Kalasi IIb ni kalasi III Implan ortopedikaw bɛ kɛnɛyaso jateminɛ gɛlɛnw sɔrɔ, fɛɛrɛko sɛbɛnw jateminɛni, ani kɛnɛyaso tuguni kɛcogo ɲuman sugu kɔfɛ (PMCF). Sannifeere ɲɛmɔgɔw ka kan k’a lajɛ ko diɲɛ kɔnɔ fɛn dilannikɛla o fɛn dilannikɛla, i n’a fɔ CZMEDITECH , o bɛ bɛnkansɛbɛn di ani ko a tɔgɔ sɛbɛnna ka dafa EUDAMED ka kunnafonidilan kɔnɔ.

J2: INFARMED ka tɔgɔsɛbɛnni wajibiyalen kɛrɛnkɛrɛnnen jumɛnw bɛ yen?

Hali ni CE Mark bɛ baara la, furakɛli minɛn o minɛn bɛ tila Pɔritigali kɔnɔ, o ka kan ka sɛbɛn ani ka ladɔnniya INFARMED ( Autoridade Nacional do Medicamento e Produtos de Saúde, IP ) la jamana ka furakɛli minɛnw sɛbɛnni dakun fɛ. Sigida jagokɛlaw ka kan k’a lajɛ ko minɛnw kunnafoniw bɛ don INFARMED kunnafonidilan kɔnɔ ka sɔrɔ ka fɛnw feere sariya sira fɛ walima ka bila foroba dɔgɔtɔrɔsow ka licitasiw kama.

J3: Mun na Helical Blade sitɛmuw (i n’a fɔ PFNA) bɛ bila jɔyɔrɔ fɔlɔ la kosɛbɛ Unidades Locais de Saúde (ULS) kɔnɔ?

Pɔritigali jamana bɛ ka kɔrɔbaya kosɛbɛ jamanaden hakɛ la, o min bɛ na ni kolotugudaw karilen caya ye foroba dɔgɔtɔrɔsow la. Laadalata lag screws ka teli ka dɛsɛ masin 'cut-out' fɛ kolo karilenw na. Sisitɛmu kɔrɔlenw sɔrɔli i n’a fɔ CZMEDITECH ka PFNA, min bɛ baara kɛ ni helical blade barikama ye walasa ka kolotugudaw digidigi sanni ka kolotugudaw sɔgɔ, o bɛ dɔ fara jiginni sabatili kan ani ka dɔgɔtɔrɔso ladonni musaka caman bali kosɛbɛ — o ye baarakɛcogo jiralan jɔnjɔn ye bi ULS rezow ka kɛnɛyaso baarakɛnafolo la.

J4: Sannifeere cɛmancɛ la SPMS fɛ, o bɛ nɔ jumɛn bila IM nɛgɛw sɔrɔli la?

SPMS Acordos ( Serviços Partilhados do Ministério da Saúde ) bɛ bɛnkansɛbɛnw ɲɛnabɔ minnu bɛ kɛ cɛmancɛ la, minnu bɛ kɛ san caman kɔnɔ ( -Quadro ) furakɛli minɛnw kan Pɔritigali. Foroba tenderiw bɛ hakilinaw jateminɛ ka da fɛɛrɛko nafaw faralen ɲɔgɔn kan (fɛnw labatoli i n’a fɔ Titaniyɔmu san 5nan, masinw sabatili, ani minɛnw ergonomi) ani sɔrɔko nafama. Diɲɛ fɛn dilannikɛlaw minnu bɛ se ka sigida dafalenw di, minnu bɛ sariyaw labato, fɛn dilanni sigidaw la, minnu bɛ se ka ɲɔgɔn sɔrɔ kosɛbɛ (i n’a fɔ CZMEDITECH ), olu jɔyɔrɔ bɛ i n’a fɔ sugandi ɲumanw walasa ka se sɔrɔ foroba kɛnɛyako bɛnkansɛbɛnw kan minnu sinsinnen bɛ hakɛ kan.

J5: Traceability ni labeling controls jumɛnw wajibiyalen don Pɔrtigal operelisow kɔnɔ?

Pɔritigali bɛ Erɔpu UDI (Unique Device Identification) siratigɛ labato kosɛbɛ . Intramedullary nail ani inter Vis da ka tugu bɛɛ ka kan ka kɛ ni barɔdi kodɔnlen ye (DataMatrix) min bɛ se ka tugu dafalen di ka bɔ a dilanni yɔrɔ la ka taa a bila banabagatɔ ka kɛnɛyako sɛbɛn digitɛri la ( Registo de Saúde Eletrónico ). Ka fara o kan, furaw taamasiɲɛw ni u ka cikan gafew ( Instruções de Utilização ) ka kan ka di ka jɛya Pɔrtigɛkan na walasa ka jamana ka lakana sariyaw labato.

J6: Yala Pɔritigali dɔgɔtɔrɔso kuluw bɛ se ka bɔnɛ sira caman fara ɲɔgɔn kan ka bɔ diɲɛ fɛn dilannikɛla kelen na wa?

Ɔwɔ, wa o bɛ dusu don kosɛbɛ musaka ni marako ɲɛnabɔli la. Ka bɔnɛ siraw sabati jɛɲɔgɔn tilennen kelen fɛ, o bɛ a to Pɔrtigal dɔgɔtɔrɔso kuluw (i n’a fɔ CUF walima Luz Saúde) walima marabolo ULS sannikɛyɔrɔw ka se ka nafa sɔrɔ sɔrɔko siratigɛ la. Ka bɔ fɛn dilannikɛla jɛlen dɔ la i n’a fɔ CZMEDITECH o b’a to dɔgɔtɔrɔso rezo ka se ka Senkɔniw, Tibial Nails, anatomical Locking platew , ani Outils électriques médicaux sɔrɔ waati kelen na—ka marako faturaw ɲɛnabɔli nɔgɔya, ka doni tali musakaw dɔgɔya, ani ka opereli labɛncogo bɛnnenw sabati baarakɛminɛnw rezow bɛɛ kɔnɔ.

Kuncɛli

K’a sɔrɔ Ameriki Woroduguyanfan ni Cɛma Erɔpu jamanaw ka laadala ciyɛn taamasiyɛnw bɛ ka taa a fɛ ka tariku suguya caman sɔrɔ Pɔritigali ka santiri fɔlɔw la, wariko ɲinini minnu bɛ ka bonya Serviço Nacional de Saúde (SNS) la, olu ye wuli ka taa fɛn dilannikɛlaw fɛ minnu bɛ se ka baara kɛ, minnu ka seereyaw bɛ diɲɛ kɔnɔ. Furakɛlaw bɛ i n’a fɔ CZMEDITECH bɛ nafa jiracogo dɔ di min bɛ mɔgɔ bila ka wale kɛ kosɛbɛ Pɔritigali bi bɔnɛko yɔrɔw la, a kɛtɔ ka Erɔpu furakɛli seereyaw ɲumanw ( CE / ISO ) ni fɛn fɔlɔ minnu bɛ se ka don fɛnw don u kɔnɔ, olu ni fɛn dilanni jɔcogo ɲumanba bɛ bɛn ɲɔgɔn ma.