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Dental X-ray Units
EUDAMEDClass IIb (EU MDR)
Ref Le Ray WModel SIRAY/SIRAY PLUS/SIRAY Max/SIRAY Mia/Le Ray P/Le Ray G/Le Ray W/Le Ray M
Identity
- Trade Name
- Dental X-ray Units EUDAMED
- Device Name
- Dental X-ray Units EUDAMED
- Model / Reference
- SIRAY/SIRAY PLUS/SIRAY Max/SIRAY Mia/Le Ray P/Le Ray G/Le Ray W/Le Ray M EUDAMEDLe Ray W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974276290462 EUDAMED
- Basic UDI-DI
- 697427629002MC EUDAMED
- Direct Marketing DI
- 06974276290462 EUDAMED
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Luxembourg EUDAMEDPoland 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
Category: Dental digital imaging sensor, intraoral
Dental X-ray Units by Zhuhai Siger Medical Equipment Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697427629002MC | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhuhai Siger Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000017163
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 53ede94d-3b9f-41e4-ab2d-2e08dc422566 61 fields · synced Jun 18, 2026
- EUDAMED bb33536f-c354-4a38-8531-cf0098820153 61 fields · synced Jun 18, 2026