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VMRD, Inc.

USA · Pullman · vmrd.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN US-MF-000049394

This company has registrations in European Union, United States, Israel — 3 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

25UDI-DI device records

IVD general 25

USUnited StatesFDA openFDA

10listed device types

Class I 4Class II 2Class III 0unclassified 4

plus 10 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

2registrations

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 Union25 raw hits, 0 excluded, 25 confirmed

United States10 registration records, 0 510(k), 0 PMA

Manufacturer names merged into this page: VMRD, Inc.

Regulatory identity

EU manufacturer SRN: US-MF-000049394
EU authorised representative: MediMark Europe Sarl.

FDA listed device types

showing 8 of 10

Babesia Spp. Serological Reagents 1Bartonella Spp. Serological Reagents 1Anaplasma Spp. And Ehrlichia Spp. Serological Reagents 1Orientia Spp. (Scrub Typhus) Serological Reagents 1Reagent, Rickettsia Serological 1Immunofluorescent Assay, T. Cruzi 1Test, Antigen, Nuclear, Epstein-Barr Virus 1Antigen, Cf, Q Fever 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00850078245281	Fuller Laboratories by VMRD Spotted Fever Rickettsia EIA IgG Antibody Kit	IVD general
EU	00850078245274	Fuller Laboratories by VMRD Typhus Group Rickettsia EIA IgM Antibody Kit	IVD general
EU	00850078245267	Fuller Laboratories by VMRD Rickettsia typhi EIA IgG Antibody Kit	IVD general
EU	00850078245250	Fuller Laboratories by VMRD Spotted Fever Rickettsia EIA IgM Antibody Kit	IVD general

VMRD, Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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