Ena / Enamel Plus
by Micerium S.p.A. EUDAMED
Active
Ref TPN2
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++EMICFAM1DVD | Date8 Feb 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- Withdrawn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
- Ena / Enamel Plus
- Model / Reference
- TPN2
- Primary DI / UDI-DI
- EMICTPN21
- Basic UDI-DI
- ++EMICFAM1DVD
- EMDN Code
- Q010199 Conservative dentistry and endodontics devices - other
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000010187
Other devices from Micerium S.p.A.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: 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