Identity
- Trade Name
- Flexible Cold Gel Pack (X-Large) EUDAMED
- Device Name
- Koolpak Reusable Hot and Cold Packs EUDAMED
- Model / Reference
- FLCPXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15026448004990 EUDAMED
- Basic UDI-DI
- 5026448Hot&ColdUH EUDAMED
- Direct Marketing DI
- 15026448004990 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Flexible Cold Gel Pack (X-Large) by CMUK Visual Safety Ltd, also trading as Koolpak Ltd — 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 | 5026448Hot&ColdUH | Class I | Active |
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Manufacturer
- Manufacturer
- CMUK Visual Safety Ltd, also trading as Koolpak Ltd
- EUDAMED SRN
- GB-MF-000002744
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED b5b70779-68b1-438a-85bf-e6dbd84568a1 61 fields · synced Jun 19, 2026