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STANBIO LABORATORY

USA · Boerne

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Singapore, South Korea — 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

pendingnot queried

USUnited StatesFDA openFDA

83listed device types

Class I 35Class II 48Class III 0

plus 87 registration records and 47 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

1valid device licences

Class I 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

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.

United States87 registration records, 47 510(k), 0 PMA

Manufacturer names merged into this page: STANBIO LABORATORY

FDA 510(k) clearances by year

21981

11982

71983

21984

11985

11987

21988

21989

11990

11993

31994

11996

11997

21998

12002

12003

32004

32005

12008

12009

FDA listed device types

showing 8 of 83

Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Drug Mixture Control Materials 1Refractometer For Clinical Use 1Ldl & Vldl Precipitation, Hdl 1Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K090093	STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM	2009-06-10
US	K081719	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM	2008-07-18
US	K050266	DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR	2005-06-30

STANBIO LABORATORY

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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