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Distal humeral plate sterile +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129700263SModel PlateRef 397129700413SRef 397129700413
by MEDIN, a.s.
Identity
- Trade Name
- Distal humeral plate sterile; Ti, extraarticular, 6 holes, 140 mm, right EUDAMEDDistal humeral plate sterile; Ti, extraarticular, 6 holes, 140 mm, left EUDAMEDDistal humeral plate; Ti, extraarticular, 6 holes, 140, left EUDAMED
- Device Name
- Distal humeral plate sterile EUDAMEDDistal humeral plate EUDAMED
- Model / Reference
- Plate EUDAMED397129700263S EUDAMED397129700413S EUDAMED397129700413 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712393518 EUDAMED08591712393501 EUDAMED08591712393266 EUDAMED
- Basic UDI-DI
- 85917126021102SPA EUDAMED85917126021102VQ EUDAMED
- Direct Marketing DI
- 08591712393518 EUDAMED08591712393501 EUDAMED08591712393266 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
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
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 (3)
- EUDAMED d0815b71-4834-4fdb-bb74-42927b4284a7 61 fields · synced Oct 6, 2026
- EUDAMED 1a223cc8-b7b5-4e53-81eb-c5edac9c18ac 61 fields · synced May 18, 2026
- EUDAMED 0c0debc8-33bf-4a34-8007-274b099e7a6a 61 fields · synced May 19, 2026