Identity
- Trade Name
- Comfort EUDAMED
- Model / Reference
- Unterarmgehstützen EUDAMED1125004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046678010619 EUDAMED
- Basic UDI-DI
- 4046678_GHMTSC-0001-130GV EUDAMED
- Direct Marketing DI
- 04046678010619 EUDAMED
- EMDN Code
- Y12030601 ELBOW CRUTCHES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Comfort by REBOTEC Rehabilitationsmittel GmbH — 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 | 4046678_GHMTSC-0001-130GV | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- REBOTEC Rehabilitationsmittel GmbH
- EUDAMED SRN
- DE-MF-000009447
Sources (1)
- EUDAMED c2368fd7-0d3b-40aa-b5af-abc6e6884282 61 fields · synced Jun 18, 2026