Valory
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
by Agfa NV
Identity
- Trade Name
- Valory EUDAMEDFDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Valory 5540 EUDAMED
- Model / Reference
- MAVV8 EUDAMED5540/100 FDA UDI
Identifiers
- Catalog Number
- MAVV8 FDA UDI
- Primary DI / UDI-DI
- 05414904275535 EUDAMEDFDA UDI
- Basic UDI-DI
- 5414904278413Z4 EUDAMED
- 510(k) Number
- K213469 FDA UDI
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb 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
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary basic diagnostic x-ray system, digital
Valory by Agfa NV — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213469 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 5414904278413Z4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
- FDA Applicant
- Agfa N.V.
Sources (3)
- EUDAMED a457893c-7866-40ed-b98d-973b7356f8fa 85 fields · synced Jun 19, 2026
- FDA UDI 565da937-2af8-423b-85a7-0cb30b0eeb84 35 fields · synced May 30, 2026
- FDA 510(k) K213469 1 fields · synced May 18, 2026