Emblation Ltd
GB-MF-000021381 · United Kingdom · Stirling
Emblation Ltd is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 5 |
|---|
Most frequent device types declared: SWF-AT01-10, SWF-CA01, SWF-GE01, SWF-HP01, SWF-SYS.
Among these devices, 4 are declared active.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- Swift Connector Cable
- Swift Generator
- Swift Handpiece
- Swift System
- Swiftip
Catalogue references include SWF-AT01-10, SWF-CA01, SWF-GE01, SWF-HP01, SWF-SYS.
European nomenclature codes declared: Z120608.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EMBLATION LIMITED (GB) · FDA 3010933564 |
| Devices in EUDAMED | 5 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 80.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EMBLATION LIMITED |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 2 |
| First licensed | 2017-01-17 |
Licence types: System (2).
Licensed under: SWIFT SYSTEM, SWIFTPRO SYSTEM.
North American profile: Both markets. Emblation Ltd is registered in both the United States and Canada.