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Hitec Medical Co., Ltd.

✓ Record-verifiedregistrations found in 3 marketsUnified social credit code 91310112574131296M

This company has registrations in United States, United Kingdom, Brazil — 3 overseas markets. No China NMPA registrations were found.

Registrations by market

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

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

17listed device types

Class I 13Class II 4Class III 0

plus 17 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

15registered device records

Class IIa 15

BRBrazilANVISA

18registered devices

Class I 2Class II 16

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

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 Union751 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States17 registration records, 0 510(k), 0 PMA

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom15 confirmed, 2 excluded

Brazil18 confirmed, 2 excluded

Manufacturer names merged into this page: HITEC MEDICAL CO., LTD · JIANGSU HITEC MEDICAL CO., LTD · HITEC MEDICAL CO. LTD

Regulatory identity

UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91310112574131296M
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2011-05-03
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: 2024-12-02
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 listed device types

showing 8 of 17

Mask, Gas, Anesthetic 1Mask, Oxygen, Low Concentration, Venturi 1Stylet, Tracheal Tube 1Bougie, Eustachian 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Mask, Oxygen, Non-Rebreathing 1Cannula, Nasal, Oxygen 1Device, Fixation, Tracheal Tube 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	10749	Suction catheter	Class IIa
UK	46967	Endotracheal tube	Class IIa
UK	47691	Endotracheal Tube	Class IIa
BR	83302999001	CATETER NASAL PARA OXIGÊNIO - TIPO ÓCULOS	Class II
BR	81325999019	Sonda foley de silicone	Class II
BR	81325999020	Cânula de Oxigênio Nasal	Class II

Hitec Medical Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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