eudamed_udi
Primary ID: D-CardiacNavigator6U
Unspecified Brand (UDI D-CardiacNavigator6U)
Manufactured by Bittium Biosignals Oy
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID D-CardiacNavigator6U
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: 9404256) is a medical device manufactured by Bittium Biosignals Oy. This product is indexed under FDA Product Code / Category Classification Z12050392 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 9404256
- Product Code / EMDN
- Z12050392
- Device Name
- Cardiac Navigator
- Database Sync Date
- 2026-08-09 17:03:11
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 Unspecified Brand?
The registered manufacturer of record for Unspecified Brand is Bittium Biosignals Oy.
What is the Primary UDI-DI identifier for Unspecified Brand?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-CardiacNavigator6U.
What classification code is assigned to this device?
This device is registered under product classification code Z12050392.
Similar Classification Devices (Z12050392)
Other Devices by Bittium Biosignals Oy
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