SCAN33
by Ningbo Rundeer Control Equipment Co., Ltd. China EUDAMED
Ref 825Model SCAN33
EMDN Z119003
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697491392IOS001Q4 | Date13 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Intraoral Scanner
- Model / Reference
- SCAN33, 825
- Primary DI / UDI-DI
- 06974913928253
- Basic UDI-DI
- 697491392IOS001Q4
- EMDN Code
- Z119003 Bioimaging photography instruments
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000040569
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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 (1)
- EUDAMED f51c6f5d-7a24-44cb-9e09-887aaaf6f4bb