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Proximal tibial plate sterile +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129703923SModel PlateRef 397129704083S
by MEDIN, a.s.
Identity
- Trade Name
- Proximal tibial plate sterile; Ti, lateral 3.5, 189 mm, 13 holes, left EUDAMEDProximal tibial plate sterile; Ti, lateral 3.5, 189 mm, 13 holes, right EUDAMED
- Device Name
- Proximal tibial plate sterile EUDAMED
- Model / Reference
- Plate EUDAMED397129703923S EUDAMED397129704083S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712394898 EUDAMED08591712394942 EUDAMED
- Basic UDI-DI
- 85917126020801SQD EUDAMED
- Direct Marketing DI
- 08591712394898 EUDAMED08591712394942 EUDAMED
- EMDN Code
- P09120502 OSTEOSYNTHESIS NEUTRALISATION AND SUPPORT PLATES EUDAMED
- Models / Variants
- Proximal tibial plate sterile EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia 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
Proximal tibial plate sterile +1 more model by MEDIN, a.s. — Class IIb — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
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 | 85917126020801SQD | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (2)
- EUDAMED 43c7cefe-2452-44e1-bd43-995e7b6a2a81 61 fields · synced Oct 6, 2026
- EUDAMED 36a81b7c-d93e-4eb3-8565-ba9b916c7597 61 fields · synced May 18, 2026