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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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Genvinset® HLA B27v5 — 2 UDI-DI variants, IVDR

MD Atlas
Blackhills Diagnostic Resources S.L.U.

Data from EUDAMED, last updated May 23, 2026

Genvinset® HLA B27v5

8437016942GVS-B27LX

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: Blackhills Diagnostic Resources S.L.U.

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 8437016942GVS-B27LX
Device name: Genvinset® HLA B27v5
Device model: Genvinset® HLA B27v5
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Jun 4, 2024

Manufacturer & authorised representative

Manufacturer

Name: Blackhills Diagnostic Resources S.L.U.
SRN: ES-MF-000001091
Country: Spain
Email: info@bdrdiagnostics.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01HE0AVKS22F3D2G8KQ387KJDC

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

GVS-B2705-2408437016942635
GVS-B2705-4808437016942642