Q-Med AB
SE-MF-000008549 · Sweden · Uppsala
Q-Med AB is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 25 |
|---|
Most frequent device types declared: New-Fill, Sculptra.
Among these devices, 25 are declared sterile, 25 implantable.
Devices declared under this manufacturer
- New-Fill
- Restylane Defyne
- Restylane Eyelight
- Restylane Kysse
- Restylane Lidocaine
- Restylane Lyft Lidocaine
- Restylane Refyne
- Restylane Skinboosters Vital Lidocaine
- Restylane Skinboosters Vital Light Lidocaine
- Restylane Volyme
- Sculptra
- Scuptra
Showing 12 of 25 declared devices.
Catalogue references include 012060, 012090, 012093, 012131, 012138, 084418.
European nomenclature codes declared: X0303, X0301, P900402.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Q-MED AB (SE) · FDA 9710154 |
| Devices in EUDAMED | 25 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 2 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | Q-MED AB |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 8 |
| First licensed | 1999-07-05 |
Licence types: Device Group Family (5), Device Family (3), System (1).
Licensed under: RESTYLANE, SCULPTRA POLY-L-LACTIC ACID DERMAL IMPLANT, AKTILITE CL 128, RESTYLANE REFYNE, RESTYLANE DEFYNE, RESTYLANE VOLYME.
North American profile: Both markets. Q-Med AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2268181TD02 | issued | 2030-12-01 |
2268181CE02 | issued | 2030-08-01 |