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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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BIOSYNEX AMPLIFLASH MALARIA — 2 UDI-DI variants, IVDR (BIOSYNEX)

MD Atlas
BIOSYNEX

Data from EUDAMED, last updated May 19, 2026

BIOSYNEX AMPLIFLASH MALARIA

353267F00191P8Q

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: BIOSYNEX

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Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 353267F00191P8Q
Device name: —
Device model: BIOSYNEX AMPLIFLASH MALARIA
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Mar 11, 2026

Manufacturer & authorised representative

Manufacturer

Name: BIOSYNEX
SRN: FR-MF-000014073
Country: France
Email: reglementaire@biosynex.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KKEJ6EFY9AHETWXE5CZA2S4J

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

315005303532678607740
3150053L03532679917558