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Bioteque Corporation

✓ Record-verifiedregistrations found in 10 marketsEU SRN TW-MF-000015568Unified social credit code 91320581663829565E

This company holds 6 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, South Korea, Australia, Hong Kong, Russia — 9 overseas markets.

Registrations by market

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

CNChinaNMPA

6China registrations

Class II 1Class III 5

as of 2026-09-01

EUEuropean UnionEUDAMED

153UDI-DI device records

Class IIa 153

USUnited StatesFDA openFDA

12listed device types

Class I 7Class II 4Class III 0unclassified 1

plus 13 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIa 2

BRBrazilANVISA

30registered devices

Class I 2Class II 28

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

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

6active registrations

Class 2a 4Class 2b 2

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, 8 excluded, 153 confirmed

United States13 registration records, 14 510(k), 0 PMA, 5 excluded

China6 certificates (Class III 5 / II 1 / I 0), as of 2026-09-01

United Kingdom2 confirmed, 1 excluded

Brazil30 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: BIOTEQUE CORP. · BIOTEQUE CORPORATION

Regulatory identity

EU manufacturer SRN: TW-MF-000015568
EU authorised representative: MedNet EC-REP GmbH
UK responsible person: It's Interventional Regulatory Limited
Unified social credit code: 91320581663829565E
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2007-07-05
Registered capital: CNY 1,000,000
Paid-in capital: CNY 1,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Wholesale trade
Last approval date: 2019-06-30
Recognitions: Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

11992

11999

22000

12001

12002

22004

12005

12011

12016

12020

12022

12025

FDA listed device types

showing 8 of 12

Tubing/Tubing With Filter, Insufflation, Laparoscopic 1Pack, Hot Or Cold, Disposable 1Device, Intravascular Catheter Securement 1Catheters, Suction, Tracheobronchial 1Laparoscopic Accessories, Gynecologic 1Catheter, Nephrostomy, General & Plastic Surgery 1Tube, Smoke Removal, Endoscopic 1System, Gastrointestinal Motility (Electrical) 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注许20163100067	内瘘管翼状针內廔管翼狀針	Class III · 2025-06-11
CN	国械注许20153100134	透析用血液回路管透析用血液回路管	Class III · 2025-04-23
CN	国械注许20183030063	血管球囊扩张导管(整体交换式)PTA Balloon Dilatation Catheter （Over The Wire）	Class III · 2024-10-16
CN	国械注许20183140074	输尿管支架套装	Class III · 2023-12-27
EU	04719882712623	BIOTEQ	Class IIa
EU	04719882712654	BIOTEQ	Class IIa
EU	04712052081512	BIOTEQ	Class IIa
EU	04713909219133	BIOTEQ	Class IIa
UK	10749	“BIOTEQ” Closed Suction Catheter Set	Class IIa
UK	47796	“BIOTEQ” Drainage Catheter Set	Class IIa
US	K251019	BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G	2025-12-22
US	K210419	BIOTEQ Drainage Catheter BT-PDS-series	2022-04-13
US	K200103	BIOTEQ Drainage Catheter Set (One Step Type)	2020-10-09
BR	10316930003	AGULHA PARA FÍSTULA COM DISPOSITIVO DE SEGURANÇA - BIO MED	Class II
BR	80053100014	Agulha para Fístula AV com Dispositivo de Segurança Farmarin	Class II
BR	10337850072	Fio Guia PTFE	Class II