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BIO/DATA CORPORATION

USA · Horsham

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Taiwan — 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

37510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 37 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 2Class II 12

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

3 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

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.

United States0 registration records, 37 510(k), 0 PMA, 44 excluded

Brazil14 confirmed, 3 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: BIO/DATA CORPORATION · BIO-DATA DO BRASIL INDUSTRIA, COMERCIO IMPORTAÇAO E EXPORTAÇAO LTDA - EPP

Same-named companies — This database also contains companies with near-identical names: BIO-DATA DO BRASIL INDUSTRIA, COMERCIO IMPORTAÇAO E EXPORTAÇAO LTDA - EPP. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K001891	MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C	2000-07-12
US	K943153	MICROSAMPLE COAGULATION ANALYZER	1995-03-24
US	K893650	PLATELET AGGREGATION PROFILER MODEL PAP-4C	1989-06-23
BR	80174889003	KIT DE SERINGA PARA INJETORA DE CONSTRASTE BIO-DATA	Class II
BR	80174889014	KIT SERINGA 200 ML BIO-INJECT BIO-DATA	Class II
BR	80174889009	PERFURADOR PUNCH BIO-DATA	Class II

BIO/DATA CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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