eudamed_udi
Primary ID: 04547410558968
FCR PRIMA II (UDI 04547410558968)
Manufactured by FUJIFILM Corporation
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for FCR PRIMA II - Primary ID 04547410558968
Device Regulatory Overview
The FCR PRIMA II (Model/Catalog Number: 04547410558968) is a medical device manufactured by FUJIFILM Corporation. This product is indexed under FDA Product Code / Category Classification Z11060201 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 04547410558968
- Product Code / EMDN
- Z11060201
- Device Name
- CR-IR 391
- Database Sync Date
- 2026-08-09 16:30:19
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of FCR PRIMA II?
The registered manufacturer of record for FCR PRIMA II is FUJIFILM Corporation.
What is the Primary UDI-DI identifier for FCR PRIMA II?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04547410558968.
What classification code is assigned to this device?
This device is registered under product classification code Z11060201.
Similar Classification Devices (Z11060201)
Other Devices by FUJIFILM Corporation
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