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Bioanalyse Tibbi Malzemeler Sanayi ve Ticaret A.S.

Türkiye · Yenimahalle -Ankara Ankara · www.bioanalyse.com

✓ Record-verifiedregistrations found in 2 marketsEU SRN TR-MF-000046898

This company has registrations in European Union, Russia — 2 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

36UDI-DI device records

IVD A 3IVD general 33

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

1active registrations

Class 1 1

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 Union36 raw hits, 0 excluded, 36 confirmed

Regulatory identity

EU manufacturer SRN: TR-MF-000046898

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08698874200446	CHLORAMPHENICOL 10 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS	IVD general
EU	08698874200439	CHLORAMPHENICOL 5 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS	IVD general
EU	08698874205137	CEFTOBIPROLE 30 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS	IVD general
EU	08698874200385	CEFTOBIPROLE 5 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS	IVD general

Bioanalyse Tibbi Malzemeler Sanayi ve Ticaret A.S.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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