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Dental X-ray Units
EUDAMEDClass IIb (EU MDR)
Ref Le Ray MModel 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 M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974276290479 EUDAMED
- Basic UDI-DI
- 697427629002MC EUDAMED
- Direct Marketing DI
- 06974276290479 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 3cc98f1a-8a8a-4464-baf2-1342c0f9aaf6 61 fields · synced Jun 19, 2026
- EUDAMED a39a3336-0d1c-45f2-870a-24062a99409b 61 fields · synced Jun 19, 2026