denture block
by Across Industrial Co., Ltd 27 variants
Ref 250121Model 250101/250102/250103/250104/250105/250106/250107/250108/250109/250110/250111/250112/250113/250114/250115/250116/250117/250118/250119/250120/250121/250122/250123/250124/250125/250126/250127
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697842977ZWDB017P 06978429770405 | Date15 Apr 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- denture block
- Model / Reference
- 250101/250102/250103/250104/250105/250106/250107/250108/250109/250110/250111/250112/250113/250114/250115/250116/250117/250118/250119/250120/250121/250122/250123/250124/250125/250126/250127, 250121
- Primary DI / UDI-DI
- 06978429770405
- Basic UDI-DI
- 697842977ZWDB017P
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000047003
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Across Industrial 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