HomeChinaHANTECH MEDICAL

HANTECH MEDICAL

China · 宁波 · www.hantechmedical.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000016465Unified social credit code 913302005994976571

This company holds 16 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, South Korea, Australia, Israel — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
16China registrations
Class II 10Class III 6
as of 2026-09-04
EUEuropean UnionEUDAMED
29UDI-DI device records
Class I 3Class IIa 26
USUnited StatesFDA openFDA
18listed device types
Class I 9Class II 9Class III 0
plus 22 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
8registered device records
Class I 4Class IIa 3IVD A 1
BRBrazilANVISA
3registered devices
Class II 3
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
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1IVD Class 1 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union29 raw hits, 0 excluded, 29 confirmed
United States22 registration records, 5 510(k), 0 PMA
China16 certificates (Class III 6 / II 10 / I 0), as of 2026-09-04
United Kingdom8 confirmed, 0 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: HANTECH MEDICAL DEVICE CO., LTD. · HANTECH (NINGBO) MEDICAL TECHNOLOGY CO., LTD. · HANTECH MEDICAL DEVICE CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000016465
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
NPZ technology Ltd
Unified social credit code
913302005994976571
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
175
Annual revenue
under RMB 5M
Website
www.hantechmedical.com
Product categories
设计及研发结构配件材料

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
2012-09-11
Registered capital
CNY 81,349,000
Paid-in capital
CNY 81,349,000
Legal form
Limited liability company (Sino-foreign joint venture)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-09-19
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMENational SRDI "Little Giant"SRDI SME

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

22022 · K221038
32023 · K231363

FDA listed device types

showing 8 of 18
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1Clamp, Umbilical 1Syringe, Piston 1Clamp And Cutter, Umbilical 1Clinical Electronic Thermometer 1Mask, Surgical 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253220753一次性使用防针刺人体动脉血样采集器Class III
CN国械注准20253220412一次性使用人体动脉血样采集器Class III
CN国械注准20243141506无针输液接头Class III
CN国械注准20243141220一次性使用无针输液接头Class III
EU06977201147374Class IIa
EU06977201147367Class IIa
EU06977201149316Micro-Fine™ Insulin SyringesClass IIa
EU06977201149217Micro-Fine™ Insulin SyringesClass IIa
UK46520Amniotic Membrane PerforatorClass IIa
UK58977BD AlarisTM Gravity Infusion SetClass I
UK58977Extension TubesClass IIa
USK231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)2023-09-27
USK222739Disposable Insulin Pen Needle2023-04-06
USK222672Disposable Insulin Syringe2023-03-06
BR81840549037AGULHA HIPODERMICA COM DISPOSITIVO DE SEGURANÇA VENPERClass II
BR82802769009Seringas Ultra-FineClass II
BR81840549022CONECTOR VALVULADO SENSINOVClass II

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