FBGC LIMITED
UK-MF-000046785 · United Kingdom · Bridlington
FBGC LIMITED is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 31 |
|---|
Most frequent device types declared: Ear Bulb Syringe, Ear Washer, Earwax Removal Syringe, Enema Irrigation Kit, Hip Ice Pack.
Authorised representative in the Union: AF Pharma Service Europe SL.
Devices declared under this manufacturer
- Douche Shower Attachments
- Ear Bulb Syringe
- Ear Washer Bottle
- Ear Washer Kit
- Earwax Removal Kit
- Earwax Removal Syringe
- Enema Irrigation Kit
- Hip Ice Pack
- Hot and Cold Breast Therapy Packs
- Migraine Relief Cap
- Nasal Rinse Bottle
- Nasal Rinse Sachets
Showing 12 of 31 declared devices.
Catalogue references include B07C2SBCDL, B0842B1XMR, B085D9VQ5W, B0F4KMQBT3, B0F546JTFJ, B0FMHWDJK6.
European nomenclature codes declared: V9099, G02060303, A03040204, A020202, Q030103, M04010203.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | FBGC LIMITED (GB) · FDA 3016585381 |
| Devices in EUDAMED | 31 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| 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. FBGC LIMITED is registered in the United States but was not found in the Canadian register.