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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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BIO-FLASH — 14 UDI-DI variants, IVDR (Biokit S.A.)

MD Atlas
Biokit S.A.

Data from EUDAMED, last updated May 23, 2026

BIO-FLASH

84269506397259T

14 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: Biokit S.A.

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 84269506397259T
Device name: BIO-FLASH
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Apr 24, 2023

Manufacturer & authorised representative

Manufacturer

Name: Biokit S.A.
SRN: ES-MF-000002406
Country: Spain
Email: oem-biokit@werfen.com
Phone: +34 938609000

Variants by status

UDI-DI variants

14 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01GYST7D3M306HD3ZQRQBSK1S4

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

3710-034408426950639725
3410-082408436003070665
3000-820608426950554448
3410-088708436003070696
3410-087208436003070702
3000-820908426950554479
3000-820708426950589433
3410-082308436003070672
3410-082508436003070689
3000-821008426950589457
3000-821108426950589464
3000-820508426950554462
3000-820408426950554455
3410-082708436003070658