dermaren SUB-Q with lidocaine
Ref R-BR0003Model dermaren SUB-Q with lidocaine
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-08800048600208 08800048600208 | Date5 Feb 2025 | 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- Withdrawn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
- Model / Reference
- dermaren SUB-Q with lidocaine, R-BR0003
- Primary DI / UDI-DI
- 08800048600208
- Basic UDI-DI
- B-08800048600208
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000036562
- Authorised representative
- MDR Regulator Sp. z o. o. PL-AR-000002485
Other devices from RFBio Co., Ltd
Properties
Other properties (8)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No