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Distal humeral plate sterile +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129700393SModel PlateRef 397129700243S
by MEDIN, a.s.
Identity
- Trade Name
- Distal humeral plate sterile; Ti, extraarticular, 4 holes, 116 mm, left EUDAMEDDistal humeral plate sterile; Ti, extraarticular, 4 holes, 116 mm, right EUDAMED
- Device Name
- Distal humeral plate sterile EUDAMED
- Model / Reference
- Plate EUDAMED397129700393S EUDAMED397129700243S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712393488 EUDAMED08591712393495 EUDAMED
- Basic UDI-DI
- 85917126021102SPA EUDAMED
- Direct Marketing DI
- 08591712393488 EUDAMED08591712393495 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 85bda136-8ed1-4585-b592-0aa05203dcdd 61 fields · synced Oct 6, 2026
- EUDAMED 98cef784-edb5-48b6-b607-825121744b4f 61 fields · synced May 17, 2026