TensCare Ltd
GB-MF-000004156 · United Kingdom · London
TensCare Ltd is registered in the European database on medical devices as a manufacturer, with 71 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 71 |
|---|
Most frequent device types declared: Adhesive Electrodes, Aliment Electrode, Cool Relief Electrodes, Garment Electrodes, Hypoallergenic Electrodes.
Among these devices, 26 are declared active.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- 100x180mm Electrode
- Liberty Fit Probe
- Liberty Mini Probe
- Neck Electrode
- New mamaTENS Electrodes
- Ova Lead Wire
- Perfect PFE for Men
- Perfect mama
- QALM
- Sure PRO
- Unifit
- iGlove Medium
Showing 12 of 71 declared devices.
Catalogue references include E-CM100180, K-GLOVE, K-PM, K-PPFE-MEN, K-QALM, K-SOCK-L.
European nomenclature codes declared: N010201, U070399, N018099, Z120622, Z12062801.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TENSCARE LTD. (GB) · FDA 3003446042 |
| Devices in EUDAMED | 71 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 71 |
|---|---|
| Found in the U.S. device database | 22 |
| Share | 31.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TENSCARE LTD. |
What it holds in Canada
| Licences on record | 14 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 14 |
| First licensed | 2012-10-15 |
Licence types: System (13), Device Group (1).
Licensed under: ELISE PELVIC FLOOR EXERCISER, PERFECT TENS, SPORTS TENS 2, PERFECT PFE, PERFECT MAMATENS, PERFECT BEAUTY.
North American profile: Both markets. TensCare Ltd is registered in both the United States and Canada.