B-Lite LWBI; Modular System (Gen I); B-Lite ;B-Lite/SL; B-Lite LWBI
by G&G Biotechnology Ltd. 1,000+ variants
Ref 30635-435LW25Model Replicon® MMS
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-07290113950443 07290113950443 | Date16 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- B-Lite LWBI
- Model / Reference
- Replicon® MMS, 30635-435LW25
- Primary DI / UDI-DI
- 07290113950443
- Basic UDI-DI
- B-07290113950443
- EMDN Code
- P0601020299 Breast implants, anatomical, made of silicone - other
- Models / Variants
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- IL-MF-000015028
- Authorised representative
- MedNet EC-REP III GmbH DE-AR-000011191
Other devices from G&G Biotechnology Ltd.
Properties
Other properties (12)
- Implantable: No
- 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