Data / Medical devices / Sweden / Q-Med AB
Q-Med AB: FDA-registered device maker in Uppsala, Sweden, 3 PMA approvals
Q-Med AB is registered with the FDA (registration 9710154) in Uppsala, Sweden. It lists 5 device types. The FDA files 3 PMA approvals under its listings, the newest dated December 9, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710154
- FEI number
- 3003347293
- Address
- Seminariegatan 21, Uppsala, Sweden, SE-752 28
- Owner or operator
- Q-MED AB (9042143)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 31, 2007
- Registered through
- 2026
- Brand names listed
- Barrigel, Deflux injectable gel, Durolane, Perlane, Restylane, Restylane Contour, Restylane Defyne, Restylane Kysse and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Hyaluronic, Intraarticular | MOZ | 3 | Contract manufacturer | accessdata.fda.gov |
| Agent, Bulking, Injectable For Gastro-Urology Use | LNM | 3 | Contract manufacturer | accessdata.fda.gov |
| Hydrogel Spacer | OVB | 2 | Contract manufacturer | accessdata.fda.gov |
| Implant, Dermal, For Aesthetic Use | LMH | 3 | Manufacturer | accessdata.fda.gov |
| Implant, Dermal, For Aesthetic Use In The Hands | PKY | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 9, 2016 | P140029 | Restylane Refyne, Restylane Defyne | LMH | 51 | September 18, 2026 | accessdata.fda.gov |
| March 25, 2005 | P040024 | RESTYLANE INJECTABLE GEL | LMH | 132 | March 12, 2026 | accessdata.fda.gov |
| August 3, 2004 | P030050 | SCULPTRA AND SCULPTRA AESTHETIC | LMH | 54 | September 17, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Bulking, Injectable For Gastro-Urology Use
- All makers of Implant, Dermal, For Aesthetic Use
- All makers of Implant, Dermal, For Aesthetic Use In The Hands
- All makers of Acid, Hyaluronic, Intraarticular
- All makers of Hydrogel Spacer
Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.