castable cap
by Dongguan Capital Healthcare Device Co., Ltd.
Ref castable capModel castable cap combined castable cap
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 | Number697574020CastableCapB3 06975740203070 | Date4 Mar 2026 | 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- Withdrawn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
- castable cap
- Model / Reference
- castable cap combined castable cap, castable cap
- Primary DI / UDI-DI
- 06975740203070
- Basic UDI-DI
- 697574020CastableCapB3
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000052357
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Dongguan Capital Healthcare Device 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