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Dental X-ray Units
EUDAMEDClass IIb (EU MDR)
Ref Le Ray PModel SIRAY/SIRAY PLUS/SIRAY Max/SIRAY Mia/Le Ray P/Le Ray G/Le Ray W/Le Ray MRef SIRAYRef SIRAY PLUSRef SIRAY Max
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 P EUDAMEDSIRAY EUDAMEDSIRAY PLUS EUDAMEDSIRAY Max EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974276290448 EUDAMED06974276290172 EUDAMED06974276290189 EUDAMED06974276290424 EUDAMED
- Basic UDI-DI
- 697427629002MC EUDAMED
- Direct Marketing DI
- 06974276290448 EUDAMED06974276290172 EUDAMED06974276290189 EUDAMED06974276290424 EUDAMED
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Luxembourg EUDAMEDAustria 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
Dental X-ray Units by Zhuhai Siger Medical Equipment 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 | 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 (8)
- EUDAMED 29bfed96-5eda-4d71-ade2-abb18ec431ea 61 fields · synced Oct 6, 2026
- EUDAMED da235900-6fcd-4ba5-925e-a6afe94128ef 61 fields · synced May 18, 2026
- EUDAMED 7cef579c-da9b-4dc9-8f43-a39214f586fd 61 fields · synced May 18, 2026
- EUDAMED feb36c41-6640-4d51-9cab-fe74f551bf2c 61 fields · synced May 19, 2026
- EUDAMED 0d056645-410a-4eee-bfdd-1646dd64911a 61 fields · synced Jul 11, 2026
- EUDAMED 88a58869-f29d-4ea3-8fc5-d9f84577d7fb 61 fields · synced Jul 14, 2026
- EUDAMED 31a0f44b-91c3-4a22-90e3-1a44af928550 61 fields · synced Jul 21, 2026
- EUDAMED baa8db5f-337a-4148-85b9-6e78267dd53c 61 fields · synced Jul 24, 2026