CMUK Visual Safety Ltd, also trading as Koolpak Ltd
GB-MF-000002744 · United Kingdom · Poole
CMUK Visual Safety Ltd, also trading as Koolpak Ltd is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 25 |
|---|
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Elly the Elephant Hot and Cold Gel Pack
- Flexible Cold Gel Pack (Large)
- Flexible Cold Gel Pack (Neck)
- Flexible Cold Gel Pack (X-Large)
- Hot and Cold Gel Sleeve
- Hot and Cold Gel Sleeve (Large)
- Hot and Cold Gel Sleeve (Medium)
- Hot and Cold Pack (Neck)
- Luxury Reusable Hot and Cold Pack 13x14cm
- Oval Hot and Cold Pack
- Reusable Hot and Cold Pack 16x28cm
- Reusable Hot and Cold Pack with Elasticated Strap and Cover
Showing 12 of 25 declared devices.
Catalogue references include FLCPN, FLCPXL, HCGSM, HCS80, LHCOV30, LHCRD60.
European nomenclature codes declared: M9001.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 25 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 25 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. CMUK Visual Safety Ltd, also trading as Koolpak Ltd was not found in either the U.S. or the Canadian register.