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Distal fibular plate +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129703723Model Plate
by MEDIN, a.s.
Identity
- Trade Name
- Distal fibular plate; Ti, 3 holes, 80 mm, left EUDAMED
- Device Name
- Distal fibular plate EUDAMED
- Model / Reference
- Plate EUDAMED397129703723 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712397486 EUDAMED
- Basic UDI-DI
- 85917126020902WR EUDAMED
- Direct Marketing DI
- 08591712397486 EUDAMED
- EMDN Code
- P09120502 OSTEOSYNTHESIS NEUTRALISATION AND SUPPORT PLATES EUDAMED
- Models / Variants
- Distal fibular plate EUDAMEDTi, 3 holes, 80 mm, left EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
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
Distal fibular plate +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 | 85917126020902WR | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (1)
- EUDAMED 67a7a64b-36d9-4255-9bb2-7d0d086c3134 61 fields · synced Aug 3, 2026