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Blackhills Diagnostic Resources, S.L.U. BDR

Spain · Zaragoza · www.bdrdiagnostics.com

✓ Record-verifiedregistrations found in 2 marketsEU SRN ES-MF-000001091

This company has registrations in European Union, United Kingdom — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

73UDI-DI device records

IVD C 45IVD general 26ivd-annex-ii-list-b 2

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

9registered device records

IVD C 8IVD general 1

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union73 raw hits, 0 excluded, 73 confirmed

United Kingdom9 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: ES-MF-000001091
UK responsible person: Qarad UK Ltd.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08436615250103	Genvinset® HLA B51 48 test	IVD C
EU	08436615250097	Genvinset® HLA B51	IVD C
EU	08436615250073	Genvinset® Thrombo panel 96 test	IVD C
EU	08436615250066	Genvinset® Thrombo panel 48 test	IVD C
UK	59291	Genvinset® HLA B27v5	IVD C
UK	63080	Genvinset® HLA Behçet v5	IVD C
UK	59914	Genvinset HLA Celiac Plus	IVD C

Blackhills Diagnostic Resources, S.L.U. BDR

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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