Dimensions (UDI CEDM Hardware Kit)
Manufactured by Hologic, Inc.
Device Regulatory Overview
The Dimensions (Model/Catalog Number: CEDM Hardware Kit) is a medical device manufactured by Hologic, Inc.. This product is indexed under FDA Product Code / Category Classification MUE within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- CEDM Hardware Kit
- Product Code / EMDN
- MUE
- Device Name
- Contrast Enhanced Digital Mammography Imaging Kit
- Database Sync Date
- 2026-08-09 09:22:50
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 Dimensions?
The registered manufacturer of record for Dimensions is Hologic, Inc..
What is the Primary UDI-DI identifier for Dimensions?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is CEDM Hardware Kit.
What classification code is assigned to this device?
This device is registered under product classification code MUE.
Similar Classification Devices (MUE)
Other Devices by Hologic, Inc.
Programmatic Export
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JSON API Endpoint