Image Receptor Positioner
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Image Receptor Positioner EUDAMEDTrans-Former FDA UDI
- Generic Name
- X-ray film cassette holder FDA UDI
- Device Name
- Image Receptor Positioner EUDAMEDDevice is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. It allows for multiple orientations of the DR panel and features wheels for mobility FDA UDI
- Model / Reference
- Image Receptor Positioner EUDAMED[T][#]-[Z] FDA UDI
- Description
- Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. It allows for multiple orientations of the DR panel and features wheels for mobility FDA UDI
Identifiers
- Catalog Number
- Digital Detector Holder FDA UDI
- Primary DI / UDI-DI
- 00860001700121 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600017001IRPositionerXB EUDAMED
- FDA Product Code
- IXY FDA UDI
- EMDN Code
- Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMED
- GMDN Term
- X-ray film cassette holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1880 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary basic diagnostic x-ray system, analogue
Image Receptor Positioner by Reina Imaging — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08600017001IRPositionerXB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Reina Imaging
- EUDAMED SRN
- US-MF-000008652
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (2)
- EUDAMED f45bc8d1-333d-4e10-9f14-2ffed3bd2cc1 61 fields · synced Jun 19, 2026
- FDA UDI bd023470-f914-4896-a406-58e28e8d7663 35 fields · synced May 30, 2026