Identity
- Trade Name
- FUJI IP CASSETTE PC EUDAMEDFDA UDI
- Generic Name
- Computed radiography digital imaging scanner FDA UDI
- Device Name
- FUJI IP CASSETTE PC EUDAMEDThe FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it. FDA UDI
- Model / Reference
- 04547410050004 EUDAMEDPC 25.2X30.3 FDA UDI
- Description
- The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410050004 EUDAMEDFDA UDI
- Basic UDI-DI
- 454741010100000000000053A EUDAMED
- 510(k) Number
- K070920 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11060280 DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Computed radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Fuji Ip Cassette Pc by FUJIFILM Corporation — 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 | 454741010100000000000053A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
- EUDAMED SRN
- JP-MF-000010401
- Authorised Representative
- FUJIFILM Healthcare Europe GmbH DE-AR-000040920
Sources (2)
- EUDAMED 6f9edaed-55a8-4a58-944c-039aa56330eb 61 fields · synced Jun 15, 2026
- FDA UDI 420a48e4-d74f-4364-8792-8bcfc687779e 37 fields · synced May 30, 2026