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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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GeneProof BK Virus (BKV) PCR Kit — 2 UDI-DI variants, IVDR

MD Atlas
GeneProof a.s.

Data from EUDAMED, last updated May 23, 2026

GeneProof BK Virus (BKV) PCR Kit

859569630027QM

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: GeneProof a.s.

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 859569630027QM
Device name: GeneProof BK Virus (BKV) PCR Kit
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Apr 29, 2026

Manufacturer & authorised representative

Manufacturer

Name: GeneProof a.s.
SRN: CZ-MF-000002370
Country: Czechia
Email: support@geneproof.com
Phone: +420 543 211 679

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KQCBWY3DWCESXHF2CD9A4G8S

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

BKV/GP/02508594161959243
BKV/GP/10008594161959267