eudamed_udi
Primary ID: 06438172218017
Neonatal Biotinidase (UDI 06438172218017)
Manufactured by Labsystems Diagnostics Oy
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Neonatal Biotinidase - Primary ID 06438172218017
Device Regulatory Overview
The Neonatal Biotinidase (Model/Catalog Number: 6199821) is a medical device manufactured by Labsystems Diagnostics Oy. This product is indexed under FDA Product Code / Category Classification W01010199 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 6199821
- Product Code / EMDN
- W01010199
- Device Name
- Neonatal Biotinidase
- Database Sync Date
- 2026-08-09 16:45:39
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 Neonatal Biotinidase?
The registered manufacturer of record for Neonatal Biotinidase is Labsystems Diagnostics Oy.
What is the Primary UDI-DI identifier for Neonatal Biotinidase?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06438172218017.
What classification code is assigned to this device?
This device is registered under product classification code W01010199.
Similar Classification Devices (W01010199)
Other Devices by Labsystems Diagnostics Oy
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