Intraoral Camera
by Shanghai Handy Medical Equipment Co., Ltd. 9 variants
Ref HDI-100AModel HDI-712D, HDI-712C, HDI-712B, HDI-220D, HDI-220C, HDI-220B, HDI-210, HDI-200A, HDI-100A
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 | Number697313088HDIQ3 06973130880238 | Date10 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- Withdrawn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
- HDI-712D, HDI-712C, HDI-712B, HDI-220D, HDI-220C, HDI-220B, HDI-210, HDI-200A, HDI-100A
- Primary DI / UDI-DI
- 06973130880238
- Basic UDI-DI
- 697313088HDIQ3
- EMDN Code
- Z11039010 Photo cameras
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000030072
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shanghai Handy Medical Equipment Co., Ltd.
See all devices from Shanghai Handy Medical Equipment 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