Anya
by Foshan Anya Medical Technology Co., Ltd.
Ref 0001Model AY-A1000, AY-A2000, AY-A3000, AY-A3600, AY-A4800I, AY-A4800II, AY-A6000, AY-A6800
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 | Number697538561IDU0001RZ 06975385600012 | Date31 Jul 2023 | 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- Withdrawn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
- Integral Dental Unit
- Model / Reference
- AY-A1000, AY-A2000, AY-A3000, AY-A3600, AY-A4800I, AY-A4800II, AY-A6000, AY-A6800, 0001
- Primary DI / UDI-DI
- 06975385600012
- Basic UDI-DI
- 697538561IDU0001RZ
- Direct Marketing DI
- 06975385600012
- EMDN Code
- Q010399 Surgical dental devices - other
- Device Class
- Class IIa
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000036804
- Authorised representative
- Wellkang Ltd XI-AR-000001836
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