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POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, Left
EUDAMEDClass IIb (EU MDR)
Ref B-261200Model POYA 3.5mm Lateral Proximal Tibia Plate
Identity
- Trade Name
- POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, Left EUDAMED
- Device Name
- POYA EUDAMED
- Model / Reference
- POYA 3.5mm Lateral Proximal Tibia Plate EUDAMEDB-261200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640187463415 EUDAMED
- Basic UDI-DI
- 764018746POYAKY EUDAMED
- Direct Marketing DI
- 07640187463415 EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic fixation plate, non-bioabsorbable
POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, Left by Bonebridge AG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764018746POYAKY | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bonebridge AG
- EUDAMED SRN
- CH-MF-000013933
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (1)
- EUDAMED ccfc7459-ddb9-4568-a193-a26f26f158d9 61 fields · synced Jun 18, 2026