Alison Hayes (Romania) SRL
RO-MF-000004583 · Romania · Urziceni
Alison Hayes (Romania) SRL is registered in the European database on medical devices as a manufacturer, with 54 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 54 |
|---|
Most frequent device types declared: Caps.
Devices declared under this manufacturer
- SYNEK Disposable Bed Mats,3 Layers,60x60cm
- SYNEK Disposable Coverall, SMMS 35gsm,Size L
- SYNEK Disposable Coverall, SMMS 35gsm,Size XXL
- SYNEK Medical Surgical Face Mask for Kids,type II,blue
- SYNEK Medical Surgical Face Mask for Kids,type II,purple
- SYNEK Medical Surgical Face Mask for Kids,type II,watermelon red
- SYNEK Medical Surgical Face Mask,type II,with earloops,purple
- SYNEK Medical Surgical Face Mask,type IIR,with earloops,white
- SYNEK Medical Surgical Face Mask,type IIR,with ties,blue
- SYNEK Standard Filter Suit-Scrub ,Size M
- SYNEK Standard Filter Suit-Scrub ,Size XL
- SYNEK Standard Non-sterile Surgical Gown, SSMMS 35gsm,Size M
Showing 12 of 54 declared devices.
Catalogue references include AH-DM11-PURPLE-E, AH-DM12-BLUE-T, AH-DM15-M, AH-DM15-S, AH-DM16-PURPLE, AH-DM18-M.
European nomenclature codes declared: T020604, T0299, T0207, T020401, T020402, T04010101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 54 |
| Country of registration | Romania |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 54 |
|---|---|
| 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. Alison Hayes (Romania) SRL was not found in either the U.S. or the Canadian register.