Dental Splints
by Debo Medical Technology (Shijiazhuang) Co., Ltd.
Ref 0.6mm FY, 1.0mm FY, 0.8mm FY, 2.0mm FYModel Square
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 | Number697700234DentalSplints9Y | Date5 Jan 2024 | 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- Withdrawn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
- Dental Splints
- Model / Reference
- Square, 0.6mm FY, 1.0mm FY, 0.8mm FY, 2.0mm FY
- Primary DI / UDI-DI
- 06977002342374, 06977002342039, 06977002342022, 06977002342060
- Basic UDI-DI
- 697700234DentalSplints9Y
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000039157
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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