Top 15 Intramedullary nail Adzɔnuwɔƒewo le Bulgaria (ƒe 2026 Nuƒle ƒe Mɔfiame)

Kpɔkplɔyiɖeme

Atikewɔnuwo ƒeƒle ƒe nɔnɔme le Bulgaria ƒe ƒumeŋutinunyalawo ƒe dɔwɔƒea le tɔtrɔm kabakaba le woƒe wɔwɔme ŋu. Dɔwɔƒewo ƒe dɔwɔwɔ nyuie ƒe sedede siwo tso Lãmesẽnyawo Gbɔkpɔha gbɔ ( Министерство на здравеопазването ) kple nuveviwɔame ƒe agbɔsɔsɔ gbogbo siwo yunivɛsitiwo ƒe habɔbɔ gãwo kple kɔdzi tɔxɛ siwo le Dukɔa ƒe Lãmesẽ Nugblẽfexeha ( НЗОК ) te—abe Pirogov Kɔdzi Kpata (Sofia), MHAT ene—ŋue ʋãe 'St. Anna' (Sofia), Yunivɛsiti Kɔdzi 'St. George' (Plovdiv), kple Dzi kple Ahɔhɔ̃ ƒe Dɔwɔƒe siwo me nu sesẽwo le ŋutɔ (Burgas kple Pleven), kpakple kɔdzi ƒe ƒuƒoƒo siwo menye dziɖuɖua tɔ o siwo de ŋgɔ abe Acibadem City Clinic kple Vita ene—kɔdzi ƒe nuƒlehawo tsɔa nusiwo wotsɔ dea ame me siwo naa atikewɔnyawo ƒe dɔwɔwɔ nyuie, sewo ƒe dedienɔnɔ, kple gazazã ƒe ɖoɖo si da sɔ nyuie la ɖoa nɔƒe gbãtɔ.

Ne wole ƒu ƒe gbagbã didiwo dzi kpɔm la, ɖaa ƒe kpeɖeŋutɔ nyuitɔ tiatia le vevie ŋutɔ le dɔwɔwɔ vɔ megbe kuxiwo dzi ɖeɖe kpɔtɔ kple dɔwɔƒewo ƒe gazazãwo dzi kpɔkpɔ le Bulgaria Dukɔa ƒe Nuƒleƒe Se ( Закон за обществените поръчки - ЗОП ) nu. Mɔfiame sia ƒo nu tso Adzɔnuwɔƒe 15 Gãtɔ Intramedullary nail siwo le Bulgaria ŋu, eye wòlé fɔ ɖe woƒe dɔwɔƒe vevitɔwo, ŋkɔ nyui si le wo si le asi me, kple mɔ̃ɖaŋununya veviwo ŋu be woakpe ɖe atikewɔlawo, ƒumeŋutinunyalawo, kple nuzazãwo ƒe kɔsɔkɔsɔ dzikpɔlawo ŋu le nyametsotso siwo wotu ɖe nyatakakawo dzi wɔwɔ me.

Mɔ̃ɖaŋununya ƒe Kekeɖenudɔwɔwɔ: Gɔmesese Tɔxɛ Intramedullary nail Aɖaŋuɖoɖowo le Egbegbe Nuveviwɔame Dzɔtsoƒe

Le atikewɔwɔ ƒe dɔbiagbalẽviwo me toto bliboe le lãmesẽnyawo gbɔ kpɔƒe xɔŋkɔwo katã me la, ƒumeŋuɖui ƒe nuveviwɔame ƒeƒle bia be woase mɔ̃ɖaŋununya gɔmesese deto le ƒumeŋuɖui ƒe mɔ̃ɖaŋununya ŋu. Intramedullary nails meganye ga-ti siwo wozãna le mɔ vovovowo nu o; egbegbe amekoko bia be woawɔ biomechanical design tɔxɛwo ŋutɔ siwo wowɔ ɖe alesi ʋua ƒe gbagbã ƒe ɖoɖo tɔxɛ kple dɔnɔa ƒe dɔléle nu.

Be woakpe ɖe kɔdzi ƒe habɔbɔwo kple amekoko kɔmitiwo ŋu be woawɔ nuveviwɔame ƒe dzɔtsoƒe ŋudɔ nyuie la, ele vevie ŋutɔ be woase Intramedullary nailwo ƒe hatsotso tɔxɛ gbãtɔ siwo xɔ aƒe ɖe egbegbe ƒumeŋutinunya ƒe fefewɔƒewo me gɔme:

1. Nusiwo wotsɔ bla ɖe wo nɔewo ŋu Intramedullary nailwo (Sesẽ vs. Cannulated) .

Tiatia si wowɔna le ɖa sesẽ kple esiwo me woɖea tsi le dome kpɔa ŋusẽ ɖe amekoko ƒe dɔwɔwɔ kple ƒu ƒe dɔyɔyɔ si me nugbagbeviwo le dzi vevie.

• Cannulated Intramedullary nailwo  : Do le titina na ɖa siawo, si wɔnɛ be woate ŋu atsɔ wo ade mɔfianu ka dzi. Aɖaŋu sia wɔnɛ be amekolawo te ŋu wɔa reamed insertion, si kekea medullary canal la ɖe enu, si wɔnɛ be woate ŋu awɔ ɖa si lolo wu eye wòsẽ wu, eye wòtsɔa teƒea ƒe ƒu si wodo ƒe kakɛwo dea teƒe si ƒu gbagbã le tẽ be wòahaya kabakaba.

• Nu sesẽ Intramedullary nailwo : Wozãnɛ koŋ le aɖaŋu siwo womeɖe o me, zi geɖe la, wotiaa ɖa sesẽwo le gbagbã sesẽ siwo le ʋuʋu ɖi alo polytrauma ƒe nyawo me be woaɖe ami ƒe ʋuka me ʋu ƒe sisi ƒe afɔkua dzi akpɔtɔ eye woaɖe ʋumenugbagbeviɣi ƒe tɔtɔ dzi akpɔtɔ.

2. Cephalomedullary Nails & Afɔkpodzi ƒe ɖoɖo siwo te ɖe wo nɔewo ŋu

Le gbagbãƒe siwo dzɔna le afɔkpodzi ƒe nuwuwu si te ɖe eŋu (akɔta ƒe nuto) gome la, ɖa siwo wotsɔ blaa wo nɔewo siwo wozãna ɖaa mesɔ gbɔ o. Wohiã na tagbɔdɔlélawo ƒe ɖoɖo tɔxɛwo be woatsɔ akpɔ ŋutilã ƒe agba siwo gbɔ eme gbɔ.

• Reconstruction Locking Configurations : Aɖaŋu siawo ƒe do tɔxɛwo le proximal tracking doles siwo ƒe dzogoe anɔ abe dzidzenu 130 va ɖo 135 ene, si wɔnɛ be lag screws siwo wɔa dɔ sesẽ la toa ɖaa me tẽ yia afɔkpodzi ƒe ta me, si wɔnɛ be subtrochanteric alo ipsilateral femoral shaft fractures la nɔa dedie.

• Anti-Rotation Helical Blade Systems : Wozãa wo koŋ le ame tsitsiwo ƒe akɔta ƒe gbagbã me, eye wotsɔa compression blade ɖɔlia lag screw xoxowo. Aɖaŋu sia ƒoa ƒu si ƒo xlãe si nye cancellous la tsɔ wu be wòaɖee ɖa, si ɖea afɔku si le 'cut-out' dede ƒu si me ƒu le me dzi kpɔtɔna ŋutɔ.

3. Retrograde vs. Anterograde Ƒu didi ƒe ɖawo

Ele be amekolawo natia mɔnu siwo tsi tre ɖe wo nɔewo ŋu siwo dzi woato age ɖe ɖaa me le afisi wogbãe le kple alesi lãkusi falɛfalɛawo le nu.

• Anterograde Sourcing : Nusiwo wotsɔ dea ame me tso nuwuƒe si te ɖe eŋu (le kpɔɖeŋu me, gege ɖe trochanter me hena afɔkpodzi ƒe gbagbã). Esia bia be woabɔbɔ ɖa pɛpɛpɛ be wòasɔ kple dzɔdzɔme ŋutilã ƒe wɔwɔme.

• Retrograde Sourcing : Nusiwo wotsɔ dea klo ƒe ƒunukpeƒe si le didiƒe (le kpɔɖeŋu me, wogena ɖe klo ƒe ƒunukpeƒea tame tututu). Afɔkpodzi ƒe ɖa tɔxɛ siwo trɔna yi megbe la ƒe nɔnɔme tɔxɛwo le didiƒe ʋĩ be woatsɔ akpɔ didiƒe etɔ̃lia ƒe supracondylar gbagbã sesẽwo ta.

Xexeame Katã ƒe Dɔwɔƒe Gãwo & Adzɔnu Xɔŋkɔwo

1. Stryker Dɔwɔƒe si Kpɔa Dɔwɔnyawo Gbɔ

Stryker si le United States nye amesi xɔ aƒe ɖe Bulgaria ƒe yunivɛsiti ƒe kadodo gbãtɔwo kple nuveviwɔame ƒe dɔwɔƒe tɔxɛwo me, eye wodea bubu eŋu ŋutɔ le eƒe mɔ̃ɖaŋudɔwɔwɔ pɛpɛpɛ kple asitsatsa ƒe kpekpeɖeŋu sesẽ ta.

• Nu Vevi Siwo Wowɔna: Ƒunukpeƒewo ɖɔliɖɔli, mɔ̃ siwo wotsɔa robot kpena ɖe wo ŋu (Mako), ahɔhɔ̃mekawo ƒe mɔ̃ɖaŋununya ƒe mɔ̃wo, kple mɔ̃ deŋgɔ siwo wotsɔ ɖɔa nuveviwɔamewo ɖo.

• Core Portfolio: Gamma4 Trochanteric Nail System kple T2 Alpha Interlocking Nail System naa mɔ̃ɖaŋununya ƒe liƒo deŋgɔ kple dɔwɔnu ƒe ɖoɖo siwo woɖo taɖodzinu na.

2. DePuy Synthes (Johnson kple Johnson ƒe MedTech) .

Esi DePuy Synthes xɔ ɖoƒe si ƒo ke ɖe to sesĩe le dukɔa ƒe kɔdzi kple ame ŋutɔ ƒe kɔdziwo siaa me le Bulgaria ta la, ewɔa dɔdamɔnu ŋuti numekuku siwo wowɔ ƒe bla nane siwo AO Foundation da megbe na ŋudɔ.

• Nu Vevi Siwo Wowɔna: Nuveviwɔame ƒe ɖoɖo siwo me kɔ, ƒunukpeƒewo gbugbɔgatu ƒe kuxiwo gbɔ kpɔnu, tagbɔ kple mo ƒe mɔ̃wo, kple aklã me nugbagbeviwo.

• Nu Vevitɔ: Expert Nail System kple TFNA (Trochanteric Fixation Nail Advanced) zãa ga ƒe atikewɔwɔ siwo nye wo tɔ siwo wowɔ wònyo wu na trochanteric kple ƒu didi ƒe gbagbã sesẽwo.

3. CZMEDITECH

Esi wònye ŋusẽtɔ si dzi woda asi ɖo le xexeame katã le ƒumeŋuɖui ƒe atikewɔnuwo me ta la, . CZMEDITECH ɖo nuzazãwo ƒe afɔɖoƒe si le kekem ɖe enu le Ɣedzeƒe Europa ƒe asi me, vevietɔ le Bulgaria me. Dɔwɔƒea xɔ ŋkɔ le alesi wòxea vovototo si le Germanytɔwo ƒe mɔ̃ɖaŋununya si sɔ pɛpɛpɛ ƒe nyonyome deŋgɔ kple adzɔnuwo wɔwɔ nyuie si me hoʋiʋli le ŋutɔ dome ta, eye dɔwɔƒea naa nuveviwɔame ŋuti agbalẽvi si me dukɔwo dome atikewɔwɔ ŋuti mɔɖeɖe sesẽwo le—siwo dometɔ aɖewoe nye ISO 13485, CE ɖaseɖigbalẽwo—si wɔe be wònye hadɔwɔla nyui aɖe na dukɔa ƒe kɔdzi gã siwo kpɔa nudzɔdzɔ kpatawo gbɔ kple ame ŋutɔ ƒe lãmesẽnyawo gbɔ kpɔha siwo le didim be yewoawɔ dɔ nyuie wu nuƒle gbogbo aɖewo le EU ƒe Dukɔa ƒe Nuƒleƒe ƒe mɔfiamewo nu.

• Ƒumeŋuɖui ƒe Nuveviwɔame ƒe Dɔwɔɖoɖowo: Deŋgɔwo ƒe Kadodo Intramedullary nailwo , Ŋutilã ƒe wɔwɔme Locking plates & Kpluwo, kple External Fixation Systems ƒe Dɔwɔɖoɖowo.

• Akɔta ƒe Kpekpeɖeŋunanuwo : Ŋgɔgbe/Megbe Vidzidɔ & Akɔta ƒe Dɔwɔɖoɖowo, Interbody Fusion Cages, kple Aklã ƒe Fixation Rods.

• Cranio-Maxillofacial ( CMF ) Implants : Titanium Plates siwo ƒe nɔnɔme le bɔbɔe ŋutɔ kple Ɖɔ Systems hena mo gbugbɔgatu.

• Amekoko ƒe Ŋusẽ Dɔwɔnuwo & Kpekpeɖeŋunuwo: Ortopedik dril s siwo wɔa dɔ nyuie, Oscillating Saws, kple sterilization instrument kits siwo sɔ.

• Customized OEM/ODM Services : Atikewɔnuwo wɔwɔ tso nuwuwu vaseɖe nuwuwu si wowɔ ɖe xexeame katã ƒe kɔdzi ƒe nɔnɔmewo nu.

• Core IM Nail Portfolio & Kadodowo:

  • Femoral Intramedullary nail : Wowɔe tso implant-grade Titanium Alloy (Ti-6Al-4V ELI) me, si me ŋutilã ƒe wɔwɔme ƒe ƒoƒo nyuie kple multi-planar locking configurations le be wòana rigid fixation na shaft fractures sesẽwo.

  • Tibial Intramedullary nail : Wowɔe kple ŋgɔyiyi ƒe proximal dynamic locking tiatia kple cannulated profile, si doa kpekpeme tsɔtsɔ kaba kple ƒu ƒe dɔyɔyɔ kabakaba ɖe ŋgɔ.

  • Humeral Intramedullary nail : Atike tɔxɛ aɖe si le etame si naa mɔnu si me womedea nu ame dzi boo o nɔa bɔbɔe, si ɖea lãmeka falɛfalɛwo ƒe tɔtɔ dzi kpɔtɔna eye wòkpɔa rotator cuff ta.

  • Proximal Femoral Nail Antirotation - PFNA : Features a helical blade system si wowɔ nyuie na ame tsitsi dɔnɔ siwo si ƒu ƒe wɔwɔme siwo me ƒu le, si kpɔa egbɔ be wotsia tre ɖe lãɖeɖe ŋu nyuie wu le trochanteric fracture fixation me.

4. Zimmer Biomet ƒe Dɔwɔƒe si Kpɔa Dɔwɔnyawo Gbɔ, Inc.

Zimmer Biomet tsɔa dijitaal lãmesẽnyawo gbɔ kpɔkpɔ ƒe mɔnuwo wɔa ɖeka kple lãmekawo ƒe ƒunukpeƒetetedɔ ƒe mɔ̃ɖaŋununya deŋgɔwo, eye wòsubɔa dugã me lãmesẽnyawo gbɔ kpɔkpɔ ƒe ɖoɖo gãwo le Bulgaria katã.

• Nu Vevi Siwo Wowɔna: Digitál lãmesẽdzidzenu siwo sɔ ɖe wo nɔewo nu, ƒunukpeƒewo ɖɔliɖɔli, kamedefefewɔtikewo ƒe xɔtunuwo, kple nuveviwɔame ƒe nusiwo wotsɔ dea lãme na ame.

• Core Portfolio: Dzɔdzɔme Nail System la ɖea ŋutilã ƒe wɔwɔme siwo wowɔ be woasɔ ɖe dɔnɔwo ƒe nɔnɔme vovovowo nu le Europatɔwo ƒe amewo ƒe xexlẽme nu la fiana.

5. Smith & Tɔgãyɔvi plc

Esi Smith & Nephew si le Eŋlisiawo wɔa dɔ tẽ le dɔ dzi tẽ eye dɔwɔƒe sesẽwo le Europa katã ta la, ebi ɖe abidzikpɔkpɔ deŋgɔwo kple nuveviwɔame ƒe ɖoɖo tɔxɛwo me.

• Nu Vevi Siwo Wowɔna: Abidzikpɔkpɔ ƒe mɔnu deŋgɔwo, ƒunukpeƒetetedɔ ƒe nukpɔkpɔ ƒe dɔwɔnuwo, kple ƒumeŋuɖui ƒe nuveviwɔame ƒe dɔwɔnuwo.

• Core Portfolio: TRIGEN Interlocking Nail System la ƒe akpa aɖewo nyea nu tɔxɛ aɖewo siwo wowɔ wòsɔ nyuie na abɔ kple afɔ ƒe gbagbã sesẽwo dzi kpɔkpɔ.

6. B. Braun Melsungen A. G. (Asculap) ƒe amegã .

B. Braun si le Germanytɔwo ƒe mɔ̃ɖaŋudɔwɔƒe deŋgɔwo teƒe la léa dɔwɔƒewo kple mama ƒe xɔtuɖoɖo si ŋu kakaɖedzi le ŋutɔ me ɖe asi le Anyiehe Europa katã, si naa Bulgaria ƒe atikewɔƒewo kpɔa nuveviwɔame ƒe ɖoɖo siwo nɔa anyi didina etɔxɛe, siwo wowɔ pɛpɛpɛ.

• Nu Vevi Siwo Wowɔna: Atikewɔwɔmɔnu siwo wozãna tsɔ daa dɔlékuiwoe, amekokodɔwɔnuwo, aklã siwo wotsɔ dea ame ƒe aklã me, kple xɔtunu siwo wotsɔ dea nuvevi ame me.

• Core Portfolio: Targon Interlocking Nail System naa ʋuƒoƒo ƒe nyateƒetoto deŋgɔ na ƒu didi ƒe afɔkpodzi kple afɔkpodzi ƒe wɔwɔmewo gbugbɔgatu sesẽ.

7. Medtronic ƒe dɔwɔƒe si nye Medtronic plc

Togbɔ be exɔ aƒe ɖe dzitodzito ƒe mɔ̃wo kple aklã ƒe mɔ̃wo me ŋutɔ hã la, Medtronic ƒe ƒumemama ƒe wɔwɔme kpɔa nudidi sesẽ siwo ku ɖe nuveviwɔame geɖe ƒe ɖɔɖɔɖo ŋu le Bulgariatɔwo ƒe nutome lãmesẽhabɔbɔwo me gbɔ.

• Nu Vevi Siwo Wowɔna: Akɔta ƒe xɔtunuwo, mɔfianu deŋgɔwo, ahɔhɔ̃mekawo ƒe dɔwɔwɔ ƒe mɔ̃wo, kple atike tɔxɛ siwo wotsɔ dea ame ƒe abi me.

• Core Portfolio: Dɔwɔnuwo ƒe nɔnɔme siwo te ŋu trɔna bɔbɔe siwo wotsɔ kpe ɖe xexeame katã ƒe ɖoɖo siwo do ƒome kple wo nɔewo siwo sɔ na ƒumeŋuɖui gbugbɔgatu si me kɔ ŋutɔ.

8. Orthofix Atikewɔwɔ ƒe Inc.

Orthofix bi ɖe ememe kple egodo fixation xexemenunyawo ƒoƒo ƒu me, enaa nugbagbewo ƒe gbugbɔgaɖɔɖo ƒe tiatia tɔxɛwo ƒumeŋutinunyalawo le Bulgaria katã.

• Nu Vevi Siwo Wowɔna: Gotagome nusiwo wotsɔna léa ƒuwoe, atike siwo doa ŋusẽ ƒu ƒe tsitsi, kple abɔ kple afɔ didi ƒe ƒuƒoƒo tɔxɛwo.

• Core Portfolio: Ðeviwo kple ame tsitsiwo ƒe micro-nailing system tɔxɛ siwo léa fɔ ɖe intertrochanteric alo shaft ƒu ƒe gbagbã sesẽwo dzi kpɔkpɔ ŋu.

9. Acumed LLC ƒe dɔwɔƒe

Acumed léa fɔ ɖe ŋutilã ƒe wɔwɔme ƒe nyateƒetoto ŋu na eƒe akpa si le etame ƒe gbagbã, eye wònaa dɔwɔnu tɔxɛ ŋutɔ siwo abɔ kple afɔ ƒe akpa sue eŋutinunyala siwo le Bulgaria ƒe atikewɔƒe xɔŋkɔwo lɔ̃na.

• Nu Vevi Siwo Wowɔna: Ŋutilã ƒe wɔwɔme Locking plates , ƒutsotsoewo ɖeɖeɖa ƒe ɖoɖo tɔxɛwo, kple ƒumeŋuɖui siwo le etame si woɖo taɖodzinu na.

• Core Portfolio: Lower-profile humeral intramedullary nails kple forearm rods siwo wowɔ be woaɖe lãmeka falɛfalɛwo ƒe ƒoƒo dzi akpɔtɔ.

10. Globus Atikewɔwɔ, Inc.

Le eƒe ƒoƒo kple NuVasive si xɔ ŋkɔ ŋutɔ nyitsɔ laa megbe la, Globus Medical keke eƒe afɔku kple nuwo gbugbɔgatu ƒe afɔɖoƒe ɖe enu kabakaba le kɔdzi ƒe kadodowo me le Titina kple Ɣedzeƒe Europa.

• Nu Vevi Siwo Wowɔna: Lãmetsiŋusẽ kple ƒunukpeƒewo ƒe kuxiwo gbɔ kpɔnu blibo, aklã ƒe dɔwɔnu deŋgɔwo, kple robot-kpeɖeŋunana ƒe mɔfiame le nuveviwɔame ŋu.

• Core Portfolio: CAPTIVATE Trauma System, si me dɔwɔnu siwo wowɔ wòsɔ nyuie siwo ŋu wotrɔ asi le be woatsɔ awɔ afɔkpodzi kple afɔkpodzi ƒe kadodo nyuie.

11. Wright Atikewɔwɔ Ƒuƒoƒo NV (A Stryker Dɔwɔƒe) .

Esi Wright Medical le dɔ wɔm le Stryker ƒe nuveviwɔame ƒe ƒomea me ta la, eƒe abɔta kple afɔkpodzi ƒe xɔtunu siwo ƒe domenyinu gakpɔtɔ nye tiatia nyuitɔ kekeake na ƒunukpeƒewo ƒe ƒoƒo kple wo ɖɔɖɔɖo sesẽwo le Bulgaria.

• Nu Vevi Siwo Wowɔna: Wodea afɔkpodzi ƒe akpa si le etame, afɔkpodzi bliboa ɖɔliɖɔli, kple ƒu si wodona le ƒumeŋuɖui me deŋgɔ.

• Core Portfolio: Afɔkpodzi kple afɔkpodzi ƒe fusion-ti tɔxɛ siwo trɔna yi megbe siwo wowɔ na ƒunukpeƒetetedɔ sesẽwo wɔwɔ.

12. Aap De AG ƒe lãme

Aap Implantate nye dɔwɔƒe aɖe si le Germany si wonya be eto klosalonu yeyewo kple dɔlékuiwutike siwo wotsɔ xea mɔ na dɔlékuiwoe vɛ be woatsɔ aɖe dɔlékui siwo dona tso nusi wotsɔ dea lãme na ame dzi akpɔtɔ.

• Nu Veviwo: LOQTEQ Locking plate ƒomea kple klosalo si wotsɔ bla dɔlékuiwutike siwo wotsɔ dea nuveviwɔame me.

• Core Portfolio: Titanium interlocking systems siwo wotsɔ cannulated kple solid wɔe siwo wotu be woaɖe kuxi siwo dona tso dɔwɔwɔ vɔ megbe dzi akpɔtɔ le ƒu didiwo ƒe nudede nyawo me me.

13. CarboFix Ƒumeŋutinunya Dɔwɔƒe.

CarboFix nye mɔɖela le carbon-fiber mɔ̃ɖaŋununya me, si naa asixɔxɔ ƒe ɖoɖo tɔxɛ aɖe ŋutɔ na ƒumeŋutinunya siwo ku ɖe kansadɔ ŋu le Bulgaria ƒe kansa ƒe dɔwɔƒe tɔxɛwo katã.

• Nu Vevi Siwo Wowɔna: polymer-gbadzɛ siwo ŋu wotsɔ carbon fiber do ŋusẽe, carbon nails siwo wotsɔ wɔa xɔtunu, kple radiolucent trauma implants.

• Core Portfolio: Piccolo Composite Nails, si ɖea mɔ na nɔnɔmetata siwo me kɔ, siwo me asinudɔwɔwɔ aɖeke mele o le kansadɔlélewo yometiti kple keklẽŋusẽdɔdamɔnu ƒe taɖodzinuwo ɖoɖo me.

14. MicroPort Dzɔdzɔmeŋutinunya Dɔwɔƒe

MicroPort zãa dɔwɔƒewo ƒe xɔtuɖoɖo si keke ta, eye wòmaa dzitodzito kple ƒumeŋuɖui ƒe tiatia siwo mexɔ asi o, siwo ƒe agbɔsɔsɔme sɔ gbɔ ɖe Ɣedzeƒe Europa ƒe mɔnuwo dzi be wòaɖo kɔdzi ƒe gazazã ƒe dzidzenu sesẽwo gbɔ.

• Nu Vevi Siwo Wowɔna: Dzitodzito me ʋuka siwo me womezãa nu boo aɖeke le o, ƒunukpeƒetetedɔ, kple nusiwo wotsɔ xea mɔ na nuveviwɔame bliboe.

• Core Portfolio: Intramedullary nail systems siwo do ƒome kple wo nɔewo siwo ŋu wotrɔ asi le hena mɔnu siwo woate ŋu agbugbɔ awɔ, siwo me wowɔa nu le bɔbɔe.

15. Wego Ortho (Weigao Ƒuƒoƒo) .

Wego Ortho nye Asia ƒe atikewɔha gãtɔwo dometɔ ɖeka, eye wòtsɔa atike siwo dzi woate ŋu aka ɖo ŋutɔ le atikewɔwɔ me siwo sɔ ɖe Europatɔwo ƒe atikewɔnyawo ƒe didi sesẽwo nu la naa amewo.

• Nu Vevi Siwo Wowɔna: Mɔ̃ siwo wotsɔ léa akɔta, xɔtunu siwo wotsɔ wɔa nuvevi ame, ƒunukpeƒetetedɔ, kple amekoko ƒe nuzazã siwo me dɔlékui mele o.

• Core Portfolio: Titanium-titanium-ƒomevi siwo nɔa anyi didina siwo wowɔ ɖe dukɔa ƒe dɔbiagbalẽviwo ƒe nubabla siwo me womezãa ga geɖe le o kple dɔbiagbalẽvi gbogbo aɖewo ƒe nubablawo le Bulgaria ƒe xexlẽme gbogbo aɖe.

── NUWO TIATIA MATRIX ──

Nya Siwo Wobiana Enuenu (FAQ) .

Q1: Ðe ɖa siwo le lãkusi me siwo hiã na Bulgaria ƒe asi hiã CE Dzesidede le EU MDR tea?

Ẽ, keŋkeŋ. Esi wònye be Bulgaria nye Europa Dukɔwo ƒe Habɔbɔ me tɔ blibo ta la, ele be dzesi si sɔ nanɔ ɖa siwo katã le lãkusi me siwo wodzrana le dukɔa me CE ŋu le Atikewɔnuwo Ŋuti Sedede (MDR 2017/745) te . Klass IIb kple Klass III Ortopedik implantwo toa mɔ̃ɖaŋu ŋuti numekuku sesẽwo kple dɔdaƒewo ƒe dodokpɔ me. Ele be nuƒlelawo nakpɔe ɖa be duta adzɔnuwɔƒe ɖesiaɖe, abe CZMEDITECH , naa Nyatakaka si le dɔ wɔm le Sewɔtakpekpe me eye woŋlɔe ɖe EUDAMED ƒe nyatakakadzraɖoƒea wòsɔ.

Q2: Nukae nye nudidi siwo le amewo ƒe ŋkɔ dede agbalẽ me le Bulgaria ƒe Atike Vɔ̃ɖiwo Ŋuti Dɔwɔƒe (BDA)?

Le Bulgariatɔwo ƒe Se si ku ɖe Atikewɔnuwo Ŋu ( Закон за медицинските изделия ) nu la, mɔ̃ siwo si dzesi CE si sɔ tso EU ƒe Habɔbɔ si Wona Ŋkɔ Na gbɔ xoxo la mehiã be woade ŋkɔ wo me ɖe vovo, si le wo ɖokui si to BDA (Bulgaria ƒe Atikewɔnyawo Gbɔkpɔha / Изпълнителна) dzi o агенция по лекарствата - ИАЛ) . Gake ne adzɔnuwɔƒea mele Europa Ganyawo ƒe Nuto (EEA) godo o la, ele be woatia Teƒenɔla si Ŋu Mɔɖeɖe Le (AR) le EU me. Ele be Bulgariatɔwo ƒe numamãla si le nutoa me hã nade woƒe asitsatsa ƒe dɔwɔnawo agbalẽ me eye wòadzra mɔ̃ɖaŋu ŋuti nuŋlɔɖiwo ɖo le nutoa me ƒe atɔ̃ ya teti nenye be BDA lé ŋku ɖe eŋu.

Q3: Nukatae Helical Blade ɖoɖowo (abe PFNA ene) nye nu vevitɔ na NHOK ƒe gazazã ƒe ɖoɖowo le Bulgaria?

Bulgaria dze ŋgɔ amewo ƒe xexlẽme ƒe kuxi ɖedzesiwo le ame tsitsiwo ta, si na ame tsitsiwo ƒe akɔta gbagbã gbogbo aɖewo. Dekɔnu lag screws ƒe kpododonu ƒe agbɔsɔsɔ gã aɖe to mɔ̃ɖaŋu 'cut-out' le ƒumeŋuɖui ƒu me. Egbɔkpɔnu deŋgɔwo abe CZMEDITECH ’s PFNA—afisi helical blade ƒoa ƒu si ƒo xlãe nu ƒu le le esi teƒe be wòaɖee ɖa—nana eƒe tɔtrɔ ƒe liƒo dzina ɖe edzi. Esia ɖea dɔwɔwɔ vɔ megbe tɔtrɔ siwo xɔa ga geɖe kple dɔnɔwo ƒe kuxiwo dzi kpɔtɔna, si le vevie ŋutɔ le Dukɔa ƒe Lãmesẽ Nugblẽfexeha ( НЗОК ) ƒe gazazã ƒe seɖoƒe sesẽwo te.

Q4: Aleke Bulgaria Dukɔa ƒe Nuƒleƒe Se (ZOP) kpɔa ŋusẽ ɖe IM ƒe ɖawo ƒe asitsatsa ƒe ɖoɖoa dzii?

Le ЗОП (Закон за обществените поръчки) te la , dukɔa ƒe kɔdziwo ƒe habɔbɔwo naa ƒe geɖe ƒe nuzazãwo ƒe nubabla siwo wotu ɖe 'dɔbiagbalẽvi si ɖea vi wu le ganyawo gome.' Mɔnu sia ƒoa Asixɔxɔ Si Wotu Ðe Nuƒle ƒe dzidzenuwo nu ƒu vevie, eye wòdea dzeside ƒe kpekpeme gã aɖe mɔ̃ɖaŋununya ƒe sedziwɔwɔ me (abe Grade 5 Titanium Alloy Ti-6Al-4V ELI nu ƒe ɖaseɖigbalẽ, ŋutilã ƒe wɔwɔme ƒe akplɔ siwo sɔ pɛpɛpɛ, kple dɔwɔnu ƒe kit ergonomics) kpe ɖe asi ŋu. Adzɔnuwɔƒe siwo naa nuwɔwɔ ƒe ɖoɖo siwo me hoʋiʋli le ŋutɔ kple sedede ƒe dedienɔnɔ (abe CZMEDITECH ) le ɖoƒe nyui aɖe ŋutɔ be woakpɔ dzidzedze le dutoƒo ƒe asitsatsa ƒe ɖoɖo siawo me.

Q5: Gbe kawo mee wòle be woatsɔ atikewo ŋuti nyatakakawo ana le Bulgaria kɔdziwo?

Le BDA ƒe sededewo nu la, Mɔfiame Siwo Ku Ðe Zazã Ŋu (IFU) ana ele be woatsɔ Bulgariagbe me nyatakaka siwo katã dze ŋgɔ dɔnɔwo, ŋkɔwo, kple . Togbɔ be ƒumeŋutinunyalawo xɔa mɔ̃ɖaŋununya ƒe amekokomɔnu ƒe mɔfiamewo le Eŋlisigbe me enuenu hã la, dɔbiagbalẽviwo ƒe dɔdzikpɔhawo wɔa nutoa me gbegɔmeɖeɖe dzi vevie hena dzesidede kple vidzidzi ƒe ɖoɖowo deŋgɔ be woalé dɔwɔƒewo ƒe dedienɔnɔ ƒe dzidzenuwo me ɖe asi.

Q6: Ðe Bulgaria kɔdzi ƒe ƒuƒoƒowo ate ŋu aɖe vi ne woƒo woƒe nuveviwɔame ƒe nuƒlemɔ̃wo nu ƒua?

Ẽ, nuwo ƒoƒo ƒu ɖekae nye mɔnu si wɔa dɔ ŋutɔ le xɔtuɖaŋu ƒe gazazã dzi ɖeɖe kpɔtɔ me. To nuveviwɔame ƒe nuƒle ƒe ɖoɖo kple adzɔnuwo wɔwɔ ƒe hadɔwɔla ɖeka abe CZMEDITECH ene me la, kɔdzi ƒe ƒuƒoƒowo alo nutome lãmesẽdɔwɔƒewo ateŋu awɔ ɖoɖo ɖe nuƒle le agbɔsɔsɔ gã me ƒe ɖoɖowo ŋu. Esia wɔnɛ be woate ŋu alé Afɔkpodzi ƒe ɖa, Afɔkpodzi ƒe ɖa, ŋutilã ƒe wɔwɔme ƒe Locking plates , kple Atikewɔwɔnu siwo wowɔ na dɔyɔyɔ ɖe te le ɣeyiɣi ɖeka me. Mɔnu sia ɖea meliɖoɖo kple dukɔmeviwo ƒe adzɔnuwo dzikpɔkpɔ ƒe masɔmasɔ bliboa dzi kpɔtɔna, eɖea ga si wozãna ɖe nudzraɖoƒewo yometiti ŋu dzi kpɔtɔna, eye wòɖoa haƒonuwo ƒe ɖoɖo si sɔ ɖe ɖoɖo nu ɖe ​​fefewɔƒewo ƒe kadodowo katã me.

Nyanuwuwuw

Togbɔ be Ɣetoɖoƒe Europa kple Dziehe Amerika ƒe domenyinu ƒe adzɔnu xoxowo yi edzi le afɔ ɖedzesi aɖe dzi kpɔm le Bulgaria ƒe atikewɔƒe siwo menye ame ŋutɔ tɔ o hã la, ganyawo ƒe mɔxenu siwo le dukɔa ƒe lãmesẽnyawo gbɔ kpɔkpɔ ƒe gazazã ( НЗОК ) kple hoʋiʋli ƒe nɔnɔme si le dukɔa ƒe dɔbiagbalẽviwo ( ЗОП ) me na wova le ŋgɔ yim vevie ɖo ta adzɔnuwɔƒe siwo le ablaɖeɖe me, siwo xɔ ɖaseɖigbalẽ le xexeame katã. Dɔwɔƒe siwo naa kpekpeɖeŋu amewo abe CZMEDITECH tsɔ asixɔxɔ ƒe nya si ŋu kakaɖedzi le ŋutɔ na Bulgaria ƒe egbegbe nuveviwɔame ƒe dɔwɔƒewo to Europatɔwo ƒe atikewɔwɔ ŋuti ɖaseɖigbalẽ deŋgɔwo ( CE / ISO ) kple nusiwo wotsɔ dea lãme na ame ƒe xɔtuɖoɖo siwo sɔ kple wo nɔewo kple nuwo wɔwɔ ƒe xɔtuɖoɖo siwo sɔ nyuie me.