FDA Registration
Active
🇸🇪 Sweden
Q-MED AB
Reg #: 9710154
·
FEI: 3003347293
·
Expires 2026
Products
5
Proprietary Names
14
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Q-MED AB
- Registration Number
- 9710154
- FEI Number
- 3003347293
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SEMINARIEGATAN 21
- City
- UPPSALA
- Country
- SE
Regulatory Submissions
- PMA Number
- P040024
Owner / Operator
- Firm Name
- Q-MED AB
- Operator Number
- 9042143
- Address
- SEMINARIEGATAN 21, --
- City
- UPPSALA
- State
- SE-C
- Postal Code
- SE-752 28
- Country
- SE
US Agent
- Business Name
- Galderma Laboratories L.P
- Contact Name
- Randy Russell
- Address
- 2001 Ross Avenue, Suite 1600
- City
- Dallas
- State
- TX
- ZIP
- 75201
- Country
- US
- [email protected]
- Phone
- 817 9615146
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Agent, Bulking, Injectable For Gastro-Urology Use | LNM | Class 3 | Unknown | No | 2011-10-17 |
| Implant, Dermal, For Aesthetic Use | LMH | Class 3 | Unknown | No | 2007-12-13 |
| Implant, Dermal, For Aesthetic Use In The Hands | PKY | Class 3 | Unknown | No | 2007-12-13 |
| Hydrogel Spacer | OVB | Class 2 | Radiology | No | 2022-07-18 |
| Acid, Hyaluronic, Intraarticular | MOZ | Class 3 | Unknown | No | 2017-09-25 |
Proprietary Names
Solesta
Restylane-L
Restylane Silk
Perlane
Restylane
Restylane Lyft with Lidocaine
Barrigel
Restylane Refyne
Restylane Defyne
Restylane Kysse
Restylane Contour
Sculptra
Deflux injectable gel
Durolane
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device