HomeChinaHaian Medigauze Co.,Ltd.

Haian Medigauze Co.,Ltd.

China · 南通 · www.medigauze.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000009960Unified social credit code 91320621733774564Q

This company holds 14 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Australia, Israel — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
14China registrations
Class I 5Class II 9
as of 2026-09-04
EUEuropean UnionEUDAMED
90UDI-DI device records
Class I 58Class IIa 32
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class I 2
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered 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
2active ARTG entries
Class I 1Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
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 Union90 raw hits, 0 excluded, 90 confirmed
United States0 registration records, 1 510(k), 0 PMA
China14 certificates (Class III 0 / II 9 / I 5), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Saudi Arabia3 confirmed, 0 excluded
Manufacturer names merged into this page: Haian Mediguaze Co., Ltd. · Haian Medigauze Co., Ltd. · Haian Medigauze Co., Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000009960
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Wellkang Ltd
Unified social credit code
91320621733774564Q
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
65
Annual revenue
RMB 100–500M
Website
www.medigauze.com

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
2002-01-14
Registered capital
CNY 20,000,000
Paid-in capital
CNY 8,800,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Textiles
Last approval date
2020-08-21
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SME

Business registration data from Tianyancha, as of 2026-09-03. 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

12021 · K212471

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20242141649一次性使用无菌手术衣Class II
CN苏械注准20222142272医用防护口罩Class II
CN苏械注准20222140939医用一次性防护服Class II
CN苏械注准20212141458医用纱布片Class II
EU16980080941541Non-Sterile Gauze Sponge with X-rayClass IIa
EU16980080941558Non-Sterile Lap Sponge without X-rayClass I
EU16973134408428Non-Sterile Lap Sponge with X-rayClass IIa
EU26973134408425Non-Sterile Lap Sponge with X-rayClass IIa
UK35091Surgical GownClass I
UK35091Surgical GownClass I
USK212471Medical Face Mask2021-11-04
BR80288090080Gaze estéril radiopaca TKlClass I
SAME0000001608SFDAA00003Medigauze
SAME0000017261SFDAA00001Non-woven face mask

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 →