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BIO SB, INC.

USA · Santa Barbara

✓ Record-verifiedregistrations found in 4 markets

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

7listed device types

Class I 7Class II 0Class III 0

plus 7 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class 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

5valid device licences

Class I 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States7 registration records, 0 510(k), 0 PMA, 2 excluded

Brazil2 confirmed, 1 excluded

Manufacturer names merged into this page: BIO SB, INC.

FDA listed device types

Immunohistochemistry Reagents And Kits 1Reagents, Specific, Analyte 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1General Purpose Reagent 1Slides, Microscope 1Hematoxylin 1Quality Control Slides 1

Market	Identifier	Name	Class / date
BR	80159760013	FAMÍLIA DE REAGENTES AUXILIARES PARA IMUNO HISTOQUIMICA	Class I
BR	80159760014	Família Sistemas de detecção para imunohistoqumica BIOSB	Class II

BIO SB, INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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