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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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ASTar BC G- Kit software CE-IVDR — 2 UDI-DI variants, IVDR

MD Atlas
Q-linea AB

Data from EUDAMED, last updated May 31, 2026

ASTar BC G- Kit software CE-IVDR

735013680500053925Y

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class C

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Manufacturer: Q-linea AB

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 735013680500053925Y
Device name: ASTar BC G- Kit software CE-IVDR
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Dec 1, 2025

Manufacturer & authorised representative

Manufacturer

Name: Q-linea AB
SRN: SE-MF-000013026
Country: Sweden
Email: regulatory@qlinea.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KBCRD6GE4WQMT6T7155AWHZK

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

ASTar BC G- Kit software CE-IVDR07350136800351
ASTar BC G- Kit software, (EUCAST)07350136800146