Identity
- Trade Name
- Drystar 5503 EUDAMEDFDA UDI
- Generic Name
- Video printer FDA UDI
- Device Name
- Printer 5364 EUDAMEDDRYSTAR 5503 FDA UDI
- Model / Reference
- ESKZV EUDAMED5364/300 FDA UDI
- Description
- DRYSTAR 5503 FDA UDI
Identifiers
- Catalog Number
- ESKZV FDA UDI
- Primary DI / UDI-DI
- 05414904015674 EUDAMEDFDA UDI
- Basic UDI-DI
- 5414904272756YT EUDAMED
- 510(k) Number
- K023287 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
Drystar 5503 by Agfa NV — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: DRYSTAR 5503
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 | 5414904272756YT | 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
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
Sources (2)
- EUDAMED dd44ae01-e195-4ac5-8e3e-a0bf39ea5df7 61 fields · synced Aug 1, 2026
- FDA UDI 5e38de21-1d96-41fe-a5dd-ea46af62fca9 36 fields · synced May 30, 2026