Restylane Shaype
by Q-Med AB Sweden EUDAMED
Ref 012354Model Restylane Shaype
EMDN X0303
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number733168901693 | Date28 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2268181TD04 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 30 Jul 2026
- Expires
- 1 Jul 2031
- 2268181CE04 Issued
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 30 Jul 2026
- Expires
- 1 Aug 2030
Specification
- Model / Reference
- Restylane Shaype, 012354
- Primary DI / UDI-DI
- 07331689123548
- Basic UDI-DI
- 733168901693
- EMDN Code
- X0303 Substances, combinations of substances, or items without an intended medical purpose intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, by a prefilled means for introduction, excluding those for tattooing – resorbable
- Device Class
- Class III
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000008549
Other devices from Q-Med AB
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
Sources (1)
- EUDAMED 618b6b38-8d8c-4747-aec5-09aad5ef75d4