GAMA Healthcare Ltd.
GB-MF-000008527 · United Kingdom · Hemel Hempstead
GAMA Healthcare Ltd. is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 37 |
|---|
Most frequent device types declared: CA2C240, CS25.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- Not Applicable
Showing 12 of 37 declared devices.
Catalogue references include CDS500, CDS500FFB, CW100B, CW140PFFFB, CW200FFB, CWAB50B.
European nomenclature codes declared: D99, Y093399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 37 |
| 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 | 37 |
|---|---|
| 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. GAMA Healthcare Ltd. was not found in either the U.S. or the Canadian register.