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Zi̇med Medi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
EUDAMEDClass IIb (EU MDR)
Ref E.5034-0003
Identity
- Trade Name
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ EUDAMED
- Device Name
- PENNING TYPE HAND-WRIST EXTERNAL FIXATOR (L) (Al) EUDAMED
- Model / Reference
- E.5034-0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-86809412601499D EUDAMED
- Basic UDI-DI
- B-86809412601499D EUDAMED
- EMDN Code
- P0912040102 AXIAL BONE FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
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
Zi̇med Medi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ by Zimed Medikal Sanayi ve Ticaret Limited Şirketi — Class IIb — MDD — listed in EUDAMED
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-86809412601499D | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zimed Medikal Sanayi ve Ticaret Limited Şirketi
- EUDAMED SRN
- TR-MF-000015401
Sources (1)
- EUDAMED bf0b3183-223e-47f8-aa84-15a0bb45e5e9 61 fields · synced Jun 18, 2026