Formeddental Crowns
by Hangzhou DTC Medical Apparatus Co., Ltd 18 variants
Ref B800-D14, B800-E45, B800-E22, B800-E44, B800-D23, B800-D12, B800-E12, B800-E24, B800-096, B800-E46, B800-D35, B800-E13, B800-E33, B800-D33, B800-D32, B800-D36, B800-E16, B800-E47, B800-D37, B800-D24, B800-E17, B800-E36, B800-240, B800-E25, B800-D45, B800-D22, B800-D26, B800-D16, B800-D43, B800-E14, B800-D42, B800-D15, B800-E37
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 | Number69419855DTCYG100017C | Date17 Oct 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- Withdrawn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
- Model / Reference
- B800-D14, B800-E45, B800-E22, B800-E44, B800-D23, B800-D12, B800-E12, B800-E24, B800-096, B800-E46, B800-D35, B800-E13, B800-E33, B800-D33, B800-D32, B800-D36, B800-E16, B800-E47, B800-D37, B800-D24, B800-E17, B800-E36, B800-240, B800-E25, B800-D45, B800-D22, B800-D26, B800-D16, B800-D43, B800-E14, B800-D42, B800-D15, B800-E37
- Primary DI / UDI-DI
- 06941985512727, 06941985513151, 06941985513007, 06941985513144, 06941985512772, 06941985512703, 06941985512949, 06941985513021, 06941985513182, 06941985513168, 06941985512857, 06941985512956, 06941985513076, 06941985512833, 06941985512826, 06941985512864, 06941985512987, 06941985513175, 06941985512871, 06941985512789, 06941985512994, 06941985513106, 06941985513199, 06941985513038, 06941985512918, 06941985512765, 06941985512802, 06941985512741, 06941985512895, 06941985512963, 06941985512888, 06941985512734, 06941985513113
- Basic UDI-DI
- 69419855DTCYG100017C
- EMDN Code
- Q01020502 Pre-formed dental crowns
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000032021
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Hangzhou DTC Medical Apparatus Co., Ltd
See all devices from Hangzhou DTC Medical Apparatus 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