Polyco Healthline Group Limited
GB-MF-000015289 · United Kingdom · Bourne, Lincolnshire
Polyco Healthline Group Limited is registered in the European database on medical devices as a manufacturer, with 182 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 181 |
|---|
Most frequent device types declared: Disposable Tourniquet, Non-Sterile, Medical Theatre Cap, Non-Sterile, Natural Latex Powder Free Examination Glove, Nitrile Powder Free Examination Glove, Non Sterile Theatre Hood/Hijab.
Authorised representative in the Union: International Associates Auditing & Certification Limited.
Devices declared under this manufacturer
- Bodyguards GL890 Blue Nitrile Powder Free Examination Glove
- HandSafe GN90 Blue Nitrile Powder Free Examination Glove
- HandSafe GN99 Blue 9 Newton Nitrile Powder Free Examination Glove
- Jangro Blue PF Nitrile Gloves
- Nitrex Extra Length Long Cuff Blue Nitrile Powder Free Glove
- Nutouch Blue Extra Strong 9N Nitrile Powder Free Disposable Glove
- Nutouch Blue Nitrile Powder Free Disposable Glove
- PIP
- SHIELD
- SHIELD Theatre Caps – Bouffant Style Green
- SafeDon Blue PF Nitrile Exam Gloves
- SafeDon Handsafe Clear vinyl powder free examination glove
Showing 12 of 182 declared devices.
Catalogue references include DG130 L, DG130 S, EGN08 L, GL890 L, GL890 S, GN99 S.
European nomenclature codes declared: T01020204, T01020201, T0207, T010201, T0299, W05010203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 182 |
| 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 | 181 |
|---|---|
| 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. Polyco Healthline Group Limited was not found in either the U.S. or the Canadian register.