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Betasan Tibbi Bant San. ve. Tic. A.S.

Türkiye · Gebze / Kocaeli · www.betasantibbi.com.tr

✓ Record-verifiedregistrations found in 3 marketsEU SRN TR-MF-000026740

This company has registrations in European Union, Brazil, Saudi Arabia — 3 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

48UDI-DI device records

Class I 40Class IIa 8

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

1registered devices

Class I 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

17registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

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.

European Union48 raw hits, 0 excluded, 48 confirmed

Brazil1 confirmed, 0 excluded

Saudi Arabia17 confirmed, 0 excluded

Manufacturer names merged into this page: Betasan Bant San Vetic A.S. · BETASAN BANT SANAYA VE TIC A.S · BETASAN BANT SANAYI VE TIC A.Ş. · Betasan Bant Sanayi ve Tic. A.S. · Betasan Bant Sanayi ve Ticaret A.S

Regulatory identity

EU manufacturer SRN: TR-MF-000026740

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08606105879491	8221 HAPPY OFTAL SANİTABANT EYEPAD 5,7 CM X 8,2 CM 5 ADET	Class I
EU	08683249002336	BETAGAUZE Steril Hidrofil Gaz Kompres 7.5 x 7.5 cm 4 kat/ kat 25 adet/adet (5 adet x 5 paket) 25'li kutu	Class IIa
EU	08683249002381	32130801 BETAGAUZE Steril Hidrofil Gaz Bezi	Class IIa
EU	08683249002398	032130801 BETAGAUZE Steril Hidrofil Gaz Kompres 30 cm x 80 cm	Class IIa
BR	80465070007	ATADURA ELÁSTICA DE ALTA COMPRESSÃO CLEARPASSAGE	Class I
SA	ME0000008951SFDAA00001	BETAIPEK	—
SA	ME0000008951SFDAA00002	BITAFIX	—

Betasan Tibbi Bant San. ve. Tic. A.S.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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