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Codonics DirectVista Thermal Film, 1436-DVB5
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1436-DVB5Model DirectVista Medical Film
Identity
- Trade Name
- Codonics DirectVista Thermal Film, 1436-DVB5 EUDAMEDFDA UDI
- Generic Name
- Medical printer film FDA UDI
- Device Name
- DVBCVPHCM01 EUDAMED1436-DVB5 Blue Base Film (25 sheet cassette) FDA UDI
- Model / Reference
- DirectVista Medical Film EUDAMED1436-DVB5 EUDAMEDFDA UDI
- Description
- 1436-DVB5 Blue Base Film (25 sheet cassette) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10814905020943 EUDAMED00814905020946 FDA UDI
- Basic UDI-DI
- 081490502DVCVHCM014Y EUDAMED
- Direct Marketing DI
- 00814905020946 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
- Netherlands 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Codonics DirectVista Thermal Film, 1436-DVB5 by Codonics Inc. — 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 | 081490502DVCVHCM014Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Codonics Inc.
- EUDAMED SRN
- US-MF-000008190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 062e0163-9ac7-46af-b52a-87e306f7b416 61 fields · synced Jun 19, 2026
- FDA UDI 0cf20e59-80ee-4961-9366-f93f3cce0952 35 fields · synced May 30, 2026