Identity
- Trade Name
- Orteza kończyny górnej EUDAMED
- Model / Reference
- AM-BX-02 EUDAMEDAM-BX-02 L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05901289131346 EUDAMED
- Basic UDI-DI
- 59009497AM-BX-02KM EUDAMED
- Direct Marketing DI
- 05901289131346 EUDAMED
- EMDN Code
- Y060627 SHOULDER-ELBOW - WRIST ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Orteza kończyny górnej by REH4MAT Spółka z ograniczoną odpowiedzialnością — Class I — MDR — listed in EUDAMED — 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 | 59009497AM-BX-02KM | Class I | Active |
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Manufacturer
- Manufacturer
- REH4MAT Spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000009271
Sources (1)
- EUDAMED 1b263563-9597-427b-bd10-d35b18964aac 61 fields · synced Oct 7, 2026