Identity
- Trade Name
- FUJI IP CASSETTE CC EUDAMEDFDA UDI
- Generic Name
- Computed radiography digital imaging scanner FDA UDI
- Device Name
- FUJI IP CASSETTE CC 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
- 04547410049510 EUDAMEDCC BW 35.4X35.4cm(14X14) 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
- 04547410049510 EUDAMEDFDA UDI
- Basic UDI-DI
- 4547410101000000000000438 EUDAMED
- 510(k) Number
- K042023 FDA UDI
- FDA Product Code
- MQB 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
- 892.1680 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 Cc 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 | 4547410101000000000000438 | 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 5694fbe6-cbee-4dd8-92e4-fad973560606 61 fields · synced Jun 18, 2026
- FDA UDI 0a5f8984-5848-4f6c-9bdd-c7979da6a4eb 37 fields · synced May 30, 2026