eudamed_udi
Primary ID: 08435287100952
Unspecified Brand (UDI 08435287100952)
Manufactured by BIOSYSTEMS S.A.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 08435287100952
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: 31047) is a medical device manufactured by BIOSYSTEMS S.A.. This product is indexed under FDA Product Code / Category Classification W01010214 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 31047
- Product Code / EMDN
- W01010214
- Device Name
- HEMOGLOBIN A1C-DIRECT (HbA1C-DIR)
- Database Sync Date
- 2026-08-09 16:29:03
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 BIOSYSTEMS S.A..
What is the Primary UDI-DI identifier for Unspecified Brand?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08435287100952.
What classification code is assigned to this device?
This device is registered under product classification code W01010214.
Similar Classification Devices (W01010214)
Other Devices by BIOSYSTEMS S.A.
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