HomeChinaSHAOXING HAITECH MEDICAL PRODUCTS CO., LTD.

SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD.

China · Shaoxing City Zhejiang Province · www.haitech-medical.com
✓ Record-verifiedregistrations found in 4 marketsUnified social credit code 91330600793396913X

This company holds 5 NMPA certificates in China and has registrations in United States, Brazil, Canada — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class I 1Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
13listed device types
Class I 12Class II 1Class III 0
plus 13 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
64registered devices
Class I 11Class II 53
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
4 including historic records
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.

United States13 registration records, 1 510(k), 0 PMA
China5 certificates (Class III 0 / II 4 / I 1), as of 2026-09-04
Brazil64 confirmed, 0 excluded
Manufacturer names merged into this page: SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD · SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD. · SHAOXING HAITECH MEDICAL PRODUCTS CO.,LTD

Regulatory identity

Unified social credit code
91330600793396913X
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Shaoxing City Zhejiang Province
Social-insurance enrolees
15
Annual revenue
RMB 10–30M
Website
www.haitech-medical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentAnaesthesia, intensive care & life-support systems

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2006-09-21
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
Software and IT services
Last approval date
2026-07-16
Recognitions
Micro and small enterpriseNational High-Tech 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

12024 · K222917

FDA listed device types

showing 8 of 13
Mask, Oxygen, Low Concentration, Venturi 1Syringe, Irrigating (Non Dental) 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Staple, Removable (Skin) 1Cannula, Nasal, Oxygen 1Device, Fixation, Tracheal Tube 1Airway, Oropharyngeal, Anesthesiology 1Catheters, Suction, Tracheobronchial 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20242081690一次性使用气管插管Class II
CN浙械注准20242081689一次性使用封闭式吸痰管Class II
CN浙械注准20232081345一次性使用喉罩气道导管Class II
CN浙械注准20232081130一次性使用呼吸过滤器Class II
USK222917Breathing circuit bacterial/viral filter2024-02-15
BR81045429021CateterClass II
BR81045429039DISPOSITIVO/CONECTOR PARA TRANSFERÊNCIA DE FLUIDOS - HAITRANSFERClass II
BR81045429040SONDA DE GASTROSTOMIA PARA NUTRIÇÃO ENTERALClass II

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