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Distal humeral plate sterile +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129700323SModel PlateRef 397129700473S
by MEDIN, a.s.
Identity
- Trade Name
- Distal humeral plate sterile; Ti, extraarticular, 12 holes, 212 mm, right EUDAMEDDistal humeral plate sterile; Ti, extraarticular, 12 holes, 212 mm, left EUDAMED
- Device Name
- Distal humeral plate sterile EUDAMED
- Model / Reference
- Plate EUDAMED397129700323S EUDAMED397129700473S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712393457 EUDAMED08591712393440 EUDAMED
- Basic UDI-DI
- 85917126021102SPA EUDAMED
- Direct Marketing DI
- 08591712393457 EUDAMED08591712393440 EUDAMED
- EMDN Code
- P09120502 OSTEOSYNTHESIS NEUTRALISATION AND SUPPORT PLATES EUDAMED
- Models / Variants
- Distal humeral 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
Distal humeral 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 | 85917126021102SPA | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (2)
- EUDAMED 7f405210-ebd6-4a96-9518-cac035ef6d29 61 fields · synced Oct 6, 2026
- EUDAMED eb03406a-5a7d-4a4d-95a4-b0eb29eb11d5 61 fields · synced May 19, 2026