Identity
- Trade Name
- Patient Positioner EUDAMEDWeight Bearing DRP Holders FDA UDI
- Generic Name
- Footstool FDA UDI
- Device Name
- Patient Positioner EUDAMEDProtect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor FDA UDI
- Model / Reference
- Patient Positioner EUDAMEDWDDR[X] FDA UDI
- Description
- Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001700176 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600017001PPositionerU8 EUDAMED
- FDA Product Code
- FZM FDA UDI
- EMDN Code
- Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMED
- GMDN Term
- Footstool FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Italy 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary basic diagnostic x-ray system, analogue
Patient 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08600017001PPositionerU8 | 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 dbc27882-02c0-4e22-b96d-77928b5fdef6 61 fields · synced Jul 24, 2026
- FDA UDI 211b237b-3b75-4c61-ba7c-88716fb1b0c7 34 fields · synced May 30, 2026