FaceFormer ONE clear
by Dr. Berndsen GmbH EUDAMED
Active
Ref DI-FF-KPGModel DI-FF-BW
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426058269FaceFormer5A | Date8 Mar 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- FaceFormer ONE blue mit Hygienebox
- Model / Reference
- DI-FF-BW, DI-FF-KPG
- Primary DI / UDI-DI
- 04260582690211
- Basic UDI-DI
- 426058269FaceFormer5A
- EMDN Code
- Q010499,Q03010299,V0899,Y99
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005561
From the manufacturer
Manufacturer's product page: FaceFormer ONEfest
Other devices from Dr. Berndsen GmbH
Properties
Other properties (13)
- Sterile: No
- 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