Orthodontic kit
by Debo Medical Technology (Shijiazhuang) Co., Ltd.
Ref blackModel black, orange, red, green, blue, purple, pink, yellow, white orcustomized
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 | Number697700234OK001BL 06977002349502 | Date8 Jul 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- Withdrawn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
- Orthodontic kit
- Model / Reference
- black, orange, red, green, blue, purple, pink, yellow, white orcustomized
- Primary DI / UDI-DI
- 06977002349502
- Basic UDI-DI
- 697700234OK001BL
- EMDN Code
- Q010499 Orthodontic devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000039157
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Debo Medical Technology (Shijiazhuang) Co., Ltd.
See all devices from Debo Medical Technology (Shijiazhuang) 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