Identity
- Trade Name
- DRYSTAR DT 2 MAMMO EUDAMEDFDA UDI
- Generic Name
- Medical printer film FDA UDI
- Device Name
- Hard Copy Film EUDAMED
- Model / Reference
- ERE5C EUDAMEDDRYSTAR DT 2 MAMMO 20x25 FDA UDI
Identifiers
- Catalog Number
- ERE5C FDA UDI
- Primary DI / UDI-DI
- 05414904015490 EUDAMEDFDA UDI
- Basic UDI-DI
- 5414904273005XE EUDAMED
- Unit of Use DI
- 05414904041956 EUDAMED
- FDA Product Code
- IWZ FDA UDI
- EMDN Code
- Z130106 DRY THERMAL PRINTER X-RAY FILMS EUDAMED
- GMDN Term
- Medical printer film FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1840 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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 — 20 Centimeter FDA UDIWidth — 25 Centimeter FDA UDI
Drystar Dt 2 Mammo 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 | 5414904273005XE | 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 8412f3df-3560-4040-883d-fb30f846cccd 61 fields · synced Jun 19, 2026
- FDA UDI aa47966a-a9a5-41ac-a2a3-415680eb49f3 36 fields · synced May 30, 2026