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Bioteque Taiwan Ltd.

Taiwan · New Taipei City

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, South Korea, Australia, Hong Kong — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 2Class II 5Class III 0

plus 13 registration records and 0 510(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

5active device licences

Class II 5

18 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

9active ARTG entries

Class I 1IIa 4IIb 1Class Is (sterile) 3

HKHong KongMDACS

1valid listings

Class III 1

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 States13 registration records, 0 510(k), 0 PMA, 7 excluded

Brazil0 confirmed, 2 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: Bioteque Taiwan Ltd. · BIOTEQUE TAIWAN LTD.

FDA listed device types

Dilator, Vaginal 1Pessary, Vaginal 1Curette, Suction, Endometrial (And Accessories) 1Cannula, Manipulator/Injector, Uterine 1Instrument, Manual, Specialized Obstetric-Gynecologic 1Sound, Uterine 1Dilator, Cervical, Fixed Size 1

Market	Identifier	Name	Class / date
CA	71675	REUSABLE OS FINDER	Class II
CA	91953	CUP PESSARY WITHOUT SUPPORT CUP PESSARY WITH SUPPORT	Class II
CA	96180	SUTURE CLOSURE GRASPER	Class II

Bioteque Taiwan Ltd.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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