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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® HFE S65C — 3 UDI-DI variants, IVDR

MD Atlas
Blackhills Diagnostic Resources S.L.U.

Data from EUDAMED, last updated May 23, 2026

Genvinset® HFE S65C

8437016942GVS-S65CZR

3 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-S65CZR
Device name: Genvinset® HFE S65C
Device model: Genvinset® HFE S65C
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

3 UDI-DI variants

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Applied filters

basicUdiUlid01HE2HMDK16NJ87VJJNG92E5QW

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-S65C-2408437016942192
GVS-S65C-4808437016942208
GVS-S65C-9608437016942758