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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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HbA1c Enzymatic — 4 UDI-DI variants, IVDR (VitalScientific)

MD Atlas
VitalScientific

Data from EUDAMED, last updated May 19, 2026

HbA1c Enzymatic

37017008HBAE0134

4 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Manufacturer: VitalScientific

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 37017008HBAE0134
Device name: HbA1c Enzymatic
Device model: HBAE-M130
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Sep 10, 2025

Manufacturer & authorised representative

Manufacturer

Name: VitalScientific
SRN: FR-MF-000004722
Country: France
Email: support@vitalscientific.com

Variants by status

UDI-DI variants

4 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01K4SJK309NEFVAPYF2DZTBD8Q

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

HbA1c Enzymatic03701700804437
HbA1c Enzymatic03701700804406
HbA1c Enzymatic03701700804413
HbA1c Enzymatic03701700804420