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Bioteque America, Inc.

USA · Richardson TX · www.bioteque.com

✓ Record-verifiedregistrations found in 6 markets

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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

6listed device types

Class I 2Class II 4Class III 0

plus 6 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIa 2

BRBrazilANVISA

1registered devices

Class 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

1active device licences

Class II 1

12 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 Union161 raw hits, 161 excluded, 0 confirmed

United States6 registration records, 10 510(k), 0 PMA, 6 excluded

United Kingdom2 confirmed, 1 excluded

Brazil1 confirmed, 1 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: BIOTEQUE AMERICA, INC. · BIOTEQUE AMERICA INC.

Regulatory identity

UK responsible person: It's Interventional Regulatory Limited

FDA 510(k) clearances by year

21992

31994 · K920747

11995 · K920633

22001 · K013289

12002 · K020628

12004 · K041094

FDA listed device types

Cannula, Manipulator/Injector, Uterine 1Curette, Suction, Endometrial (And Accessories) 1Pessary, Vaginal 1Dilator, Vaginal 1Sound, Uterine 1Dilator, Cervical, Fixed Size 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	10749	“BIOTEQ” Closed Suction Catheter Set	Class IIa
UK	47796	“BIOTEQ” Drainage Catheter Set	Class IIa
US	K041094	HSG CATHETER SET	2004-06-17
US	K020628	CURELLE, PREFERRED CURELLE, CUTEQ 2.5	2002-05-24
US	K013289	BIOTEQUE VAGINAL PESSARIES	2001-12-27
BR	80386689018	HSG Catheter Set Bioteque	Class II
CA	21681	BIOTEQUE SILICONE PESSARY	Class II

Bioteque America, Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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