Nagor Limited
by Nagor Limited United Kingdom EUDAMED
Ref TE-XM3 600Model TE-XF3 150 EMDN P900103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-00606401172119 | Date8 Dec 2022 | StatusActive |
| European Union | CE/MDD | NumberB-00606401172119 | Date8 Dec 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD Active
Certificates
- MDR 773742 Cancelled
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 5 Jun 2025
- Expires
- 28 Nov 2029
- Reason
- Other
Specification
- Trade Name
- Nagor LimitedBlossom™ IVTE
- Device Name
- Integrated Valve Tissue Expander. Anatomical Textured – Moderate Height, High ProjectionIntegrated Valve Tissue Expander
- Model / Reference
- TE-XM3 600, TE-XF3 150
- Primary DI / UDI-DI
- 00606401172119
- Basic UDI-DI
- B-00606401172119, 006064011C2005BP
- Direct Marketing DI
- 00606401172119
- EMDN Code
- P900103 Breast tissue expanders
- 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 d855b488-bbdf-443a-878f-698523372705
- EUDAMED 00606401172119|006064011C2005BP