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Singlera Genomics Co., Ltd.

✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000033428

This company has registrations in European Union, United Kingdom, South Korea — 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

pendingnot queried

EUEuropean UnionEUDAMED

9UDI-DI device records

IVD A 8IVD general 1

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

1registered device records

IVD 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

1GMP quality-system certificates

IVD import 1

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 Union9 raw hits, 0 excluded, 9 confirmed

United Kingdom1 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: CN-MF-000033428
EU authorised representative: SUNGO Europe B.V.
UK responsible person: PURE GENETIC MEDICAL

Registration details (sample)

Market	Identifier	Name	Class / date
EU	16975970650276	Bisulfite Conversion Kit (Magnetic Beads)	IVD A
EU	16975970650283	Bisulfite Conversion Kit (Magnetic Beads)	IVD A
EU	06975970650064	Bisulfite Conversion Kit (Spin Column)	IVD A
EU	06975970650057	Bisulfite Conversion Kit (Spin Column)	IVD A
UK	59010	BT-REVEAL or PDACatch	IVD general

Singlera Genomics Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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