Identity
- Trade Name
- Luxury Reusable Hot and Cold Pack 13x14cm EUDAMED
- Device Name
- Koolpak Reusable Hot and Cold Packs EUDAMED
- Model / Reference
- LHCS80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15026448000299 EUDAMED
- Basic UDI-DI
- 5026448Hot&ColdUH EUDAMED
- Direct Marketing DI
- 15026448000299 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
Luxury Reusable Hot and Cold Pack 13x14cm by CMUK Visual Safety Ltd, also trading as Koolpak Ltd — Class I — MDR — listed in EUDAMED
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 548e5110-d3e1-42ce-b538-b784e6c756b3 61 fields · synced Jun 19, 2026