Koalaa Ltd
UK-MF-000045260 · United Kingdom · London
Koalaa Ltd is registered in the European database on medical devices as a manufacturer, with 788 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 788 |
|---|
Most frequent device types declared: ABOVE ELBOW, ALX, JOEYY, PAWW, UPPER LIMB.
Authorised representative in the Union: European Healthcare & Device Solutions Ltd..
Devices declared under this manufacturer
- ALX Cosmetic Cover, Large, 14
- ALX Cosmetic Hand Child, Left, Small 9
- ALX Cosmetic Hand, Child, Right, Large, 13
- ALX Cosmetic Hand, Men, Right, Large, 4
- ALX Cosmetic Hand, Men, Right, Large, c3
- ALX Cosmetic Hand, Men, Right, Small, 1
- Foam Soft 58x10mm, Orange
- Paww Cosmetic Cover, Large, 1
- Paww Cosmetic Cover, Large, 14
- Paww Cosmetic Cover, Large, 16
- Paww Cosmetic Cover, Large, 17
- Paww Cosmetic Cover, Medium, 14
Showing 12 of 788 declared devices.
Catalogue references include KCH127, KCH13, KCH382, KCHC150, KCHC152, KCHC153.
European nomenclature codes declared: Y061809, Y061803, Y061899, Y061815, Y061803,Y061806,Y061809, Y061806,Y061809.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | KOALAA (GB) · FDA 3017907747 |
| Devices in EUDAMED | 788 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 788 |
|---|---|
| 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: United States only. Koalaa Ltd is registered in the United States but was not found in the Canadian register.