Dental X-ray Unit
by Shanghai Handy Medical Equipment Co., Ltd. China EUDAMED
Ref HDX-7030, HDX-6520, HDX-6030Model HDX-7030, HDX-7020, HDX-6520, HDX-6030
EMDN Z1103040101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697313088HDXQZ | Date3 Jul 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- HDX-7030, HDX-7020, HDX-6520, HDX-6030
- Primary DI / UDI-DI
- 06973130880320, 06973130880344, 06973130880351
- Basic UDI-DI
- 697313088HDXQZ
- EMDN Code
- Z1103040101 Equipment for conventional endoral radiology
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000030072
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (3)
- EUDAMED fa1fac4a-3a7b-4a7f-bc6d-13be88f9f176
- EUDAMED 06973130880344|697313088HDXQZ
- EUDAMED 06973130880351|697313088HDXQZ