← Back to catalogue
Comfort Cool Ulnar Nerve Elbow Orthosis
EUDAMEDClass I (EU MDR)
Ref NC33850-3Model 646Ref NC33850-1Ref NC33850-4
Identity
- Trade Name
- Comfort Cool Ulnar Nerve Elbow Orthosis EUDAMED
- Device Name
- Comfort Cool Ulnar Nerve Elbow Orthosis EUDAMED
- Model / Reference
- 646 EUDAMEDNC33850-3 EUDAMEDNC33850-1 EUDAMEDNC33850-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627001793 EUDAMED00768627001816 EUDAMED00768627001809 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-646-72 EUDAMED
- Direct Marketing DI
- 00768627001793 EUDAMED00768627001816 EUDAMED00768627001809 EUDAMED
- EMDN Code
- Y060618 ELBOW-WRIST ORTHOSES 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 Cool Ulnar Nerve Elbow Orthosis by North Coast Medical, Inc. — 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 | 0768627ORTHO-646-72 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (3)
- EUDAMED 12534f34-46a2-43ec-be63-6d0724758a14 61 fields · synced Jul 19, 2026
- EUDAMED bdc84065-89b7-4b04-8e3e-d5eec2830709 61 fields · synced May 18, 2026
- EUDAMED ae73cf76-b82c-44de-a3d3-fc9c5ade38a6 61 fields · synced May 18, 2026