BTL Industries Limited
GB-MF-000034894 · United Kingdom · Stevenage
BTL Industries Limited is registered in the European database on medical devices as a manufacturer, with 65 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 30 |
|---|---|
| Class IIa | 35 |
Most frequent device types declared: 713/1, 713/2, Applicator Easy, Applicator Magnum, BTL Vanquish ME.
Among these devices, 39 are declared active.
Authorised representative in the Union: BTL ITALIA S.r.l..
Devices declared under this manufacturer
- 713/1
- Applicator Easy
- BTL-6000 FSWT
- BTL-6000 Microwave 250
- BTL-6000 RSWT Elite
- Capacitive applicator BTL-249-APC1
- Coupling pad BTL-294-CP1F Small
- FSWT Applicator arm
- Full set of transmitters
- Patient cable for resistive electrodes BTL-249-CABR
- Resistive electrode 30 mm BTL-249-R30
- Resistive electrode 50 mm BTL-249-R50
Showing 12 of 65 declared devices.
Catalogue references include 844-APEA-M, P014.060, P094.001, P094.011, P6000.510, P6000.535.
European nomenclature codes declared: Z12139001, Z12069099, Z120608, X0402,Z120609, Z12011019, V0880.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 65 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BTL INDUSTRIES LIMITED |
What it holds in Canada
| Licences on record | 44 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 33 |
| Class 3 devices | 11 |
| First licensed | 2009-07-03 |
Licence types: System (24), Device Family (13), Single Device (5), Device Group Family (2).
Licensed under: BTL-SWT SERIES SHOCKWAVE UNITS, BTL-6000 LYMPHASTIM UNITS, LYMPHASTIM APPLICATORS, EXILIS, VANQUISH, 215/3 ELECTRODE.
North American profile: Canada only. BTL Industries Limited holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 2036797-1 | supplemented | 2028-02-02 |
051/MDR | supplemented | 2027-10-06 |