Identity
- Trade Name
- DS830 EUDAMED
- Device Name
- Image Plate Scanner EUDAMED
- Model / Reference
- DS830, DS630 EUDAMEDIFU-DS-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974721258122 EUDAMED
- Basic UDI-DI
- 697472125CR001D6 EUDAMED
- EMDN Code
- Z11060201 SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ds830 by Ningbo Runyes Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697472125CR001D6 | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Runyes Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000014741
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 01aab5fc-a522-42d3-8bfb-a1c456c34799 61 fields · synced Oct 6, 2026