Nagor Limited
by Nagor Limited EUDAMED
Active
Ref SOR-MR 280Model SOR
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-00606401180046 | Date5 Oct 2022 | StatusActive |
| European Union | CE/MDD | NumberB-00606401180046 | Date5 Oct 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD 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
- Trade Name
- Nagor LimitedPerle™
- Device Name
- PERLE TM gel-filled mammary implants: soft, high cohesive gel-filled smooth- moderate rangePERLE Gel Filled Mammary Implant
- Model / Reference
- SOR-MR 280, SOR
- Primary DI / UDI-DI
- 00606401180046
- Direct Marketing DI
- 00606401180046
- Market of Registration
- Northern IrelandAustria
Manufacturer details
- EUDAMED SRN
- GB-MF-000019179
- Authorised representative
- GC Aesthetics (Management) Limited IE-AR-000004118