Identity
- Trade Name
- Crystal Imager EUDAMEDFDA UDI
- Generic Name
- Video printer FDA UDI
- Device Name
- Printer 5366 EUDAMEDCRYSTAL IMAGER FDA UDI
- Model / Reference
- 5YGND EUDAMED5366/300 FDA UDI
- Description
- CRYSTAL IMAGER FDA UDI
Identifiers
- Catalog Number
- 5YGND FDA UDI
- Primary DI / UDI-DI
- 05414904161470 EUDAMEDFDA UDI
- Basic UDI-DI
- 5414904272763YQ EUDAMED
- 510(k) Number
- K032635 FDA UDI
- FDA Product Code
- LMC FDA UDI
- EMDN Code
- Z110706 VIDEO OR DIGITAL BIOIMAGING PLAYERS EUDAMED
- GMDN Term
- Video printer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2040 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Crystal Imager by Agfa NV — Class I — 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 | 5414904272763YQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
Sources (2)
- EUDAMED b1d0b79f-76fb-4d33-bc5f-0d226732dd26 61 fields · synced Jun 19, 2026
- FDA UDI 55f7e69c-4d08-4a0e-bc00-3c9ad3ba1684 36 fields · synced May 30, 2026