Ortho Model
by Loyol New Material Suhzou Co., Ltd. 4 variants
Ref C2015160002Model V1
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 | Number697842008OrthoModelV1YJ 06978420080183 | Date23 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- Withdrawn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
- Model / Reference
- V1, C2015160002
- Primary DI / UDI-DI
- 06978420080183
- Basic UDI-DI
- 697842008OrthoModelV1YJ
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000045820
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Loyol New Material Suhzou 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