Perle Gel Filled Mammary Implant
by Nagor Limited United Kingdom EUDAMED
Ref SOR-LR 400Model SOR
EMDN P0601010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number006064011B1001AV | Date29 Jul 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 773740 Cancelled
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 13 May 2025
- Expires
- 12 May 2030
- Reason
- Other
Specification
- Model / Reference
- SOR, SOR-LR 400
- Primary DI / UDI-DI
- 00606401000900
- Basic UDI-DI
- 006064011B1001AV
- Direct Marketing DI
- 00606401000900
- EMDN Code
- P0601010201 Breast implants, round, made of silicone, with smooth surface
- Device Class
- Class III
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- GB-MF-000019179
- Authorised representative
- GC Aesthetics (Management) Limited IE-AR-000004118
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 00606401000900|006064011B1001AV