Image Receptor Protector
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Image Receptor Protector EUDAMEDProtect-A-Grid FDA UDI
- Generic Name
- Stationary x-ray grid FDA UDI
- Device Name
- Image Receptor Protector EUDAMEDThe "Protect-A-Grid" line of Premium Grid Encasements house x-ray grids in either Polycarbonate or Aluminum shells. They may also be used with 14x17” film or CR cassettes. They house an x-ray grid to be used in general radiography. Their secondary purpose is to hold a DR Panel during exams. " FDA UDI
- Model / Reference
- Image Receptor Protector EUDAMEDP[2][X]DR[NG][Y] FDA UDI
- Description
- The "Protect-A-Grid" line of Premium Grid Encasements house x-ray grids in either Polycarbonate or Aluminum shells. They may also be used with 14x17” film or CR cassettes. They house an x-ray grid to be used in general radiography. Their secondary purpose is to hold a DR Panel during exams. " FDA UDI
Identifiers
- Catalog Number
- Premium Grid Encasement FDA UDI
- Primary DI / UDI-DI
- 00860001700183 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600017001IRProtector52 EUDAMED
- FDA Product Code
- IXY FDA UDI
- EMDN Code
- Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary x-ray grid 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 Protector by Reina Imaging — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary basic diagnostic x-ray system, analogue.
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- SEDECAL — Sedecal., Sa. · Class II
- Q-RAD System — CARESTREAM HEALTH, INC. · Class II
- X-CEL X-RAY CORPORATION — ARQUILLA, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- FDR Smart FGXR-E32S — DRGEM Corporation · Class IIb
- DRGEM — DRGEM Corporation · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08600017001IRProtector52 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reina Imaging
- EUDAMED SRN
- US-MF-000008652
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (2)
- EUDAMED eb9b850c-f3dd-411d-89e2-84a805156ccb 61 fields · synced Jul 12, 2026
- FDA UDI 056c1e48-1baf-49cb-9acc-cec585dd53a5 35 fields · synced May 29, 2026