Pro-Lab Diagnostics UK
GB-MF-000003833 · United Kingdom · Bromborough
Pro-Lab Diagnostics UK is registered in the European database on medical devices as a manufacturer, with 269 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Inoclic, Rabbit Coagulase Plasma, Salmonella Agglutination Sera, Shigella Agglutination Sera, Stains.
Among these devices, 1 are declared sterile.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Crystal Violet (500ml)
- Differentiator for ZN & Kinyoun Carbol Fuchsin (250ml)
- Dilute Carbol Fuchsin concentrate (400ml)
- Factor 7
- Factor i
- Factor z32
- Gram's Staining kit (Dilute Carbol Fuchsin) (4x250ml)
- Grams Differentiator (97% IMS/3% Acetone) (500ml)
- Group E Factor 3, 10, 15, 19, 34
- Group R Factor 40
- Kinyoun Carbol Fuchsin (1000ml)
- Methylene Blue (500ml)
Showing 12 of 269 declared devices.
Catalogue references include PL.6038, PL.6133, PL.6148, PL.6156, PL.7000, PL.7022.
European nomenclature codes declared: W0104010804, W01029001, W0104050102, W0104030404, W0105011203, W0103010302.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 269 |
| 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 | 269 |
|---|---|
| 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. Pro-Lab Diagnostics UK was not found in either the U.S. or the Canadian register.