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Universal plate +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129717820Model PlateRef 397129717820S
by MEDIN, a.s.
Identity
- Trade Name
- Universal plate; reconstruction, 3.5 COMBI, 8 holes, 112 mm EUDAMEDUniversal plate sterile; reconstruction, 3.5 COMBI, 8 holes, 112 mm EUDAMED
- Device Name
- Universal plate EUDAMEDUniversal plate sterile EUDAMED
- Model / Reference
- Plate EUDAMED397129717820 EUDAMED397129717820S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712402517 EUDAMED08591712402715 EUDAMED
- Basic UDI-DI
- 85917126020105VP EUDAMED85917126020105SP8 EUDAMED
- Direct Marketing DI
- 08591712402517 EUDAMED08591712402715 EUDAMED
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
- Models / Variants
- Universal plate EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
Universal 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 | 85917126020105VP | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (2)
- EUDAMED 1f8d0968-1cb5-4ee5-a1b2-096e53464ef2 61 fields · synced Jul 10, 2026
- EUDAMED f2dec7a0-b828-4ec2-b190-fe87ca123023 61 fields · synced May 18, 2026