Scuptra
by Q-Med AB Sweden EUDAMED
Ref 085557Model Sculptra
EMDN X0301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number73316890138V | Date27 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2268181TD02 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 3 Dec 2025
- Expires
- 1 Dec 2030
- 2268181CE02 Issued
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 3 Dec 2025
- Expires
- 1 Aug 2030
Specification
- Device Name
- Sculptra
- Model / Reference
- Sculptra, 085557
- Primary DI / UDI-DI
- 07331689855579
- Basic UDI-DI
- 73316890138V
- EMDN Code
- X0301 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, excluding those for tattooing – resorbable
- Device Class
- Class III
- Market of Registration
- Italy
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 (11)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 922b7e94-3a37-4467-9d3a-0634740c63d2