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Gold Standard Diagnostics Frankfurt GmbH

Germany · Dietzenbach · clinical.goldstandarddiagnostics.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN DE-MF-000025020

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Hong Kong, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

IVD general 300

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

8listed device types

Class I 5Class II 3Class III 0

plus 16 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

101registered device records

IVD general 101

BRBrazilANVISA

4registered devices

Class II 4

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

32valid device licences

Class I 19Class II 13

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

IVD Class 2 8IVD Class 3 6

HKHong KongMDACS

1valid listings

IVD C 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2b 1

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 Union420 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States16 registration records, 0 510(k), 0 PMA, 3 excluded

United Kingdom101 confirmed, 0 excluded

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: Gold Standard Diagnostics Frankfurt GmbH · GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH

Regulatory identity

EU manufacturer SRN: DE-MF-000025020
UK responsible person: Werfen Ltd

FDA listed device types

Antigen, Fluorescent Antibody Test, Schistosoma Mansoni 1Reagents, Cysticercosis 1Elisa, Trichinella Spiralis 1Antigen, Agglutinating, Echinococcus Spp. 1Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. 1Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. 1Antisera, Fluorescent, Brucella Spp. 1Reagent, Borrelia Serological Reagent 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	+ENTIPRES61310F	—	IVD general
EU	+ENTIPRES61340I	—	IVD general
EU	+ENTI301136240G	—	IVD general
EU	+ENTIEBVA01500P	—	IVD general
UK	49867	Adenovirus IgA	IVD general
UK	49869	Adenovirus IgG	IVD general
UK	49872	Adenovirus IgM	IVD general
BR	80464810917	NovaLisa® Toxocara canis IgG ELISA	Class II
BR	80464810918	NovaLisa® Taenia solium IgG ELISA	Class II
BR	80213250751	NovaLisa® Toxocara canis IgG	Class II