HomeChinaSuzhou Haowei Medical Technology Co., Ltd

Suzhou Haowei Medical Technology Co., Ltd

China · 苏州 · www.hiwemed.com
✓ Record-verifiedregistrations found in 3 marketsUnified social credit code 91320506MA25DR8U62

This company holds 4 NMPA certificates in China and has registrations in United States, Brazil — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class II 1Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
1 including historic records
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 Union2 raw hits, 2 excluded, 0 confirmed
United States1 registration records, 2 510(k), 0 PMA
China4 certificates (Class III 3 / II 1 / I 0), as of 2026-09-04
Manufacturer names merged into this page: SUZHOU HAOWEI MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

Unified social credit code
91320506MA25DR8U62
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
68
Annual revenue
RMB 10–30M
Website
www.hiwemed.com
Product categories
手术器械植入器械

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
2021-03-15
Registered capital
CNY 3,816,947
Paid-in capital
CNY 3,500,287
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-08-24
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based 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

12023 · K231554
12026 · K252812

FDA listed device types

Device, Vascular, For Promoting Embolization 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253030117可调弯微导管Class III
CN国械注准20243131548聚乙烯醇丙烯酸钠栓塞微球Class III
CN国械注准20243030738封堵球囊导管系统Class III
CN苏械注准20252140545重组胶原蛋白疤痕凝胶Class II
USK252812UniPearls® Embolic Microspheres2026-07-31
USK231554UniPearls® Embolic Microspheres2023-11-14

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →