GBUK Group
GB-MF-000002238 · United Kingdom · Selby
GBUK Group is registered in the European database on medical devices as a manufacturer, with 586 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 492 |
|---|---|
| Class IIb | 90 |
Most frequent device types declared: 7752016, ABS-PFCO-20-EU, B-EGT100200-P, BAISO1, CF01.08.092ISOSAF.
Among these devices, 285 are declared sterile, 198 with a measuring function.
Authorised representative in the Union: Qualrep Services B.V..
Catalogue references include 7752016, ABS-PFCO-20-EU, BAISO3-S, CF01.08.092ISOSAF, EGT090200, EISO-100.
European nomenclature codes declared: V0805038002, G02020101, V0899, A020108, Z1203020302, A070199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GBUK GROUP LIMITED (GB) · FDA 3007441619 |
| Devices in EUDAMED | 586 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 586 |
|---|---|
| Found in the U.S. device database | 235 |
| Share | 40.1 % |
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. GBUK Group is registered in the United States but was not found in the Canadian register.