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C-Luminary Biotechnology Co., Ltd.

✓ Record-verifiedregistrations found in 2 marketsEU SRN CN-MF-000035089

This company has registrations in European Union, Russia — 2 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

pendingnot queried

EUEuropean UnionEUDAMED

≥300UDI-DI device records

IVD A 13IVD general 287

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

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 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

pendingnot queried

RURussiaRoszdravnadzor

12active registrations

Class 2a 12

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 Union500 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

Regulatory identity

EU manufacturer SRN: CN-MF-000035089
EU authorised representative: Share info GmbH

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06980070461984	Fully Automated CLIA Analyzer Sharay 800	IVD A
EU	06975070768294	Sharay Anti-Myositis Antibody Profile IgG (CLIA)	IVD general
EU	06975070769284	Sharay Anti-Myositis Antibody Profile IgG (CLIA)	IVD general
EU	06980070460550	Sharay Anti-U1-RNP (CLIA)	IVD general

C-Luminary Biotechnology Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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