Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

BIOSYNEX AMPLIQUICK Bordetella — 2 UDI-DI variants, IVDR (BIOSYNEX)

MD Atlas
BIOSYNEX

Data from EUDAMED, last updated May 19, 2026

BIOSYNEX AMPLIQUICK Bordetella

353267F00133P7Y

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

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 353267F00133P7Y
Device name: —
Device model: BIOSYNEX AMPLIQUICK Bordetella
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

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01KKEEGAE3MVAWRYC5AV36JSTJ

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

3150068_SEC0103532678593685
3150068_SEC0203532678593692