Clinical Laserthermia Systems AB
SE-MF-000016898 · Sweden · Lund
Clinical Laserthermia Systems AB is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 |
|---|
Most frequent device types declared: 3001-01, 4013-14.
Among these devices, 11 are declared sterile.
Devices declared under this manufacturer
- TRANBERG MR Introducer
- TRANBERG Tissue Temperature Probe
- Tranberg MR Introducer
Catalogue references include 3001-02, 3002-02, 3003-01, 3004-01, 3004-02, 4013-14.
European nomenclature codes declared: Z12011085.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CLINICAL LASERTHERMIA SYSTEMS AB (SE) · FDA 3012452798 |
| Devices in EUDAMED | 11 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 11 |
| Share | 100.0 % |
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: United States only. Clinical Laserthermia Systems AB is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 081830 0011 | issued | 2029-11-26 |