Identity
- Trade Name
- Comfortgel Hot/Cold Therapy Mitt EUDAMED
- Device Name
- Comfortgel Hot/Cold Therapy EUDAMED
- Model / Reference
- 4411 EUDAMEDNC13253 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627011365 EUDAMED
- Basic UDI-DI
- 0768627REHAB-4411-S3 EUDAMED
- Direct Marketing DI
- 00768627011365 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Hot/cold therapy pack, reusable
Comfortgel Hot/Cold Therapy Mitt by North Coast Medical, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0768627REHAB-4411-S3 | Class I | Active |
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Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED 6538f222-fcab-4a1d-aeeb-6dfd93e22e15 61 fields · synced Jun 19, 2026