Nagor Limited
by Nagor Limited United Kingdom EUDAMED
Ref SOR-MR 165Model SOR
EMDN P0601010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-00606401180008 | Date5 Oct 2022 | StatusActive |
| European Union | CE/MDD | NumberB-00606401180008 | Date5 Oct 2022 | StatusActive |
Coverage
- Active
- 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 165, SOR
- Primary DI / UDI-DI
- 00606401180008
- Basic UDI-DI
- B-00606401180008, 006064011B1001AV
- Direct Marketing DI
- 00606401180008
- EMDN Code
- P0601010201 Breast implants, round, made of silicone, with smooth surface
- Device Class
- Class III
- Market of Registration
- Northern IrelandAustria
Manufacturer details
- EUDAMED SRN
- GB-MF-000019179
- Authorised representative
- GC Aesthetics (Management) Limited IE-AR-000004118
Other devices from Nagor Limited
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 (2)
- EUDAMED 3f9d6f9f-93c9-48e1-9059-837413ce0aa5
- EUDAMED 00606401180008|006064011B1001AV