eudamed_udi
Primary ID: 05425023680902
BlueDot Granular12 IgG (UDI 05425023680902)
Manufactured by D-tek s.a.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BlueDot Granular12 IgG - Primary ID 05425023680902
Device Regulatory Overview
The BlueDot Granular12 IgG (Model/Catalog Number: GR12D-24) is a medical device manufactured by D-tek s.a.. This product is indexed under FDA Product Code / Category Classification W0102100112 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- GR12D-24
- Product Code / EMDN
- W0102100112
- Device Name
- BlueDot Granular12 IgG
- Database Sync Date
- 2026-08-09 17:15:21
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 BlueDot Granular12 IgG?
The registered manufacturer of record for BlueDot Granular12 IgG is D-tek s.a..
What is the Primary UDI-DI identifier for BlueDot Granular12 IgG?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05425023680902.
What classification code is assigned to this device?
This device is registered under product classification code W0102100112.
Similar Classification Devices (W0102100112)
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