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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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HELICOBACTER PYLORI AB RAPID TEST… — 1 UDI-DI variant, IVDR

MD Atlas
VitroBioChem SRL

Data from EUDAMED, last updated May 31, 2026

HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)

5944759080VTHPB25SPROB6HC

1 UDI-DI variant

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: VitroBioChem SRL

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 5944759080VTHPB25SPROB6HC
Device name: HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)
Device model: HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: May 25, 2026

Manufacturer & authorised representative

Manufacturer

Name: VitroBioChem SRL
SRN: RO-MF-000010877
Country: Romania
Email: office@vitro.ro
Phone: +40214118833

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01KSFQ5552DT2NDF4DXGX1C4VZ

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

HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)05944759080010