3 pcs Pack (Universal St, Basic)
Ref A・UNOModel Dental Resin
Active
CE MDR
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/MDR | Number456023117D10B104N001VH 04580797161024 | Date7 Mar 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- A・uno
- Model / Reference
- Dental Resin, A・UNO
- Primary DI / UDI-DI
- 04580797161024
- Basic UDI-DI
- 456023117D10B104N001VH
- EMDN Code
- Q01010103 Dental restorative composites
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- JP-MF-000011382
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Yamakin Co., Ltd.
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