← Back to catalogue
Zi̇med Medi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
EUDAMEDClass IIb (EU MDR)
Ref 1972-0012
Identity
- Trade Name
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ EUDAMED
- Device Name
- HIGH TIBIA OSTEOTOMY PLATE WEDGE 12 mm (TI) EUDAMED
- Model / Reference
- 1972-0012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8680941253691AF EUDAMED
- Basic UDI-DI
- B-8680941253691AF EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic fixation plate, non-bioabsorbable
Zi̇med Medi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ by Zimed Medikal Sanayi ve Ticaret Limited Şirketi — Class IIb — MDD — listed in EUDAMED
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-8680941253691AF | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimed Medikal Sanayi ve Ticaret Limited Şirketi
- EUDAMED SRN
- TR-MF-000015401
Sources (1)
- EUDAMED d6e3b7b3-8da0-457a-9551-ddd44ab1094a 61 fields · synced Jun 18, 2026