Identity
- Trade Name
- FDR-2000BPY EUDAMEDFDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- Biopsy Positioner EUDAMEDThe FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the image obtained from an exposure and supports the positioning of the needle using the coordinates. FDA UDI
- Model / Reference
- 04547410242294 EUDAMEDPOSITIONER KIT BPSY HA USA E FDA UDI
- Description
- The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the image obtained from an exposure and supports the positioning of the needle using the coordinates. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410242294 EUDAMED04547410327342 FDA UDI
- Basic UDI-DI
- 454741010100000000000894A EUDAMED
- FDA Product Code
- IZH FDA UDIMUE FDA UDI
- EMDN Code
- Z1103028001 STEREOTACTIC MODULES FOR MAMMOGRAPHY EUDAMED
- GMDN Term
- Stationary mammographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1710 FDA UDI892.1715 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary mammographic x-ray system, digital
Fdr-2000bpy by FUJIFILM Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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K191495 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (2)
- FDA UDI 8470c9ac-37fa-40f0-93cf-e7b90e695c8f 36 fields · synced Jul 31, 2026
- EUDAMED 6d470978-3276-4d14-ae7b-88002019822a 61 fields · synced Jul 31, 2026