Identity
- Trade Name
- YOU98(P) EUDAMED
- Device Name
- Diagnostic X-ray Equipment EUDAMED
- Model / Reference
- YOU98(P) EUDAMED710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974721257101 EUDAMED
- Basic UDI-DI
- 697472125YOU98001C5 EUDAMED
- EMDN Code
- Z1103040101 EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
You98(p) by Ningbo Runyes Medical Instrument Co., Ltd. — Class IIb — 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 | 697472125YOU98001C5 | Class IIb | 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 e9769e45-df38-44fd-9c30-98ac4bb08b31 61 fields · synced Jun 19, 2026