Identity
- Trade Name
- Comfort SCS EUDAMED
- Model / Reference
- BU00059 EUDAMEDAK1L0W1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05690967925307 EUDAMED
- Basic UDI-DI
- 5690967BU00059NS EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 SCS by Össur Iceland ehf. — 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 | 5690967BU00059NS | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Össur Iceland ehf.
- EUDAMED SRN
- IS-MF-000000173
Sources (1)
- EUDAMED 1d1f7844-4118-4bfa-8f6a-ce5635305190 61 fields · synced Sep 17, 2026