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Pluto0001X Digital intraoral X-ray imaging system
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 03160066Model Pluto0000X
by iRay Group
Identity
- Trade Name
- Pluto0001X Digital intraoral X-ray imaging system EUDAMEDDigital Intraoral X-ray Imaging System FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- Digital intraoral X-ray imaging system EUDAMEDThe Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric. FDA UDI
- Model / Reference
- Pluto0000X EUDAMED03160066 EUDAMEDPluto0001X FDA UDI
- Description
- The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric. FDA UDI
Identifiers
- Catalog Number
- / FDA UDI
- Primary DI / UDI-DI
- 06970569090252 EUDAMEDFDA UDI
- Basic UDI-DI
- 697056909INTRAORALSR7E EUDAMED
- Direct Marketing DI
- 06970569090252 EUDAMED
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMED
- GMDN Term
- Dental digital imaging sensor, intraoral FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pluto0001X Digital intraoral X-ray imaging system by iRay Group — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697056909INTRAORALSR7E | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- iRay Group
- EUDAMED SRN
- CN-MF-000037606
- Authorised Representative
- iRay Europe GmbH DE-AR-000007525
Sources (2)
- EUDAMED 74bbad3c-8165-4305-8673-a311ca68d358 61 fields · synced Jun 18, 2026
- FDA UDI 17afa1e1-5a32-4d05-884f-f1ba46ec8571 34 fields · synced May 30, 2026