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Affimedix, Inc.

✓ Record-verifiedregistrations found in 4 marketsEU SRN US-MF-000053178

This company has registrations in European Union, United States, United Kingdom, Brazil — 4 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

23UDI-DI device records

IVD general 23

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

2registered device records

IVD general 2

BRBrazilANVISA

1registered devices

Class II 1

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 Union23 raw hits, 0 excluded, 23 confirmed

United States1 registration records, 0 510(k), 0 PMA

United Kingdom2 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: AFFIMEDIX, INC. · AFFIMEDIX INC.

Regulatory identity

EU manufacturer SRN: US-MF-000053178
EU authorised representative: QbD RepS BV
UK responsible person: Qarad UK Ltd.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00850082432172	Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test	IVD general
EU	00850082432042	botissCARE Rapi-D™ Quantitative Vitamin D Test	IVD general
EU	00850082432226	25 OH Quantitative Rapid Vitamin D Test	IVD general
EU	00850082432219	OnSight™ - Vitamin B12 Quantitative Test	IVD general
UK	66124	TestNOW® - Ferritin Quantitative Test	IVD general
UK	60955	botissCARE Rapi-D™ Quantitative Vitamin D Test	IVD general
BR	80583710010	TESTE RÁPIDO 25-OH VITAMINA D	Class II

Affimedix, Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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