Identity
- Trade Name
- CR MD1.0 GENERAL SET EUDAMEDFDA UDI
- Generic Name
- Digital imaging cassette/phosphor plate FDA UDI
- Device Name
- CR MD1.0 Set EUDAMEDCR MD1.0 GENERAL SET 35X43 FDA UDI
- Model / Reference
- 5R3GU EUDAMEDCR MD1.0 GENERAL SET 35X43 FDA UDI
- Description
- CR MD1.0 GENERAL SET 35X43 FDA UDI
Identifiers
- Catalog Number
- 5R3GU FDA UDI
- Primary DI / UDI-DI
- 05414904092521 EUDAMEDFDA UDI
- Basic UDI-DI
- 5414904272947Z4 EUDAMED
- 510(k) Number
- K131408 FDA UDI
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11060280 DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Digital imaging cassette/phosphor plate FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Belgium 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 35 Centimeter FDA UDIWidth — 43 Centimeter FDA UDI
Cr Md1.0 General Set by Agfa NV — 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 | 5414904272947Z4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
Sources (2)
- EUDAMED 97ba1224-94ba-4291-9a19-70397ece7d35 61 fields · synced Jun 20, 2026
- FDA UDI 2dc0d233-feb6-4139-8606-a527f8b2aedc 37 fields · synced May 30, 2026