HomeChinaSHANGHAI MOTEX HEALTHCARE CO., LTD.

SHANGHAI MOTEX HEALTHCARE CO., LTD.

China · 上海 · www.shmotex.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000016264Unified social credit code 91310000607332749G

This company holds 6 NMPA certificates in China and has registrations in European Union, United States, Brazil, Taiwan, South Korea, Israel — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
6China registrations
Class I 2Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
1UDI-DI device records
Class I 1
USUnited StatesFDA openFDA
4listed device types
Class I 4Class II 0Class III 0
plus 9 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
5registered devices
Class I 3Class II 2
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
4valid device licences
Class I 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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 Union36 raw hits, 35 excluded, 1 confirmed
United States9 registration records, 8 510(k), 0 PMA, 2 excluded
China6 certificates (Class III 0 / II 4 / I 2), as of 2026-09-04
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: SHANGHAI MOTEX HEALTHCARE CO., LTD. · SHANGHAI MOTEX HEALTHCARE CO., LTD · SHANGAI MOTEX HEALTHCARE CO. LTD · Motex Healthcare Corp.

Regulatory identity

EU manufacturer SRN
CN-MF-000016264
EU authorised representative
Euregio Business Center
Unified social credit code
91310000607332749G
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
81
Annual revenue
RMB 100–500M
Website
www.shmotex.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
1995-12-01
Registered capital
USD 3,200,000
Paid-in capital
USD 3,200,000
Legal form
Limited liability company (wholly owned by a foreign corporation)
Industry classification
Rubber and plastic products
Last approval date
2023-07-25

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

12001
12002
12003
12004
12007
12013
22014

FDA listed device types

Latex Patient Examination Glove 1Polymer Patient Examination Glove 1Surgeon'S Gloves 1Medical Glove, Specialty 1

Registration details (sample)

MarketIdentifierNameClass / date
CN沪械注准20262140160一次性使用医用碘伏棉片Class II
CN沪械注准20262140144一次性使用医用酒精棉片Class II
CN沪械注准20212140211一次性使用医用橡胶检查手套Class II
CN沪械注准20172140706一次性使用灭菌橡胶外科手套Class II
EU06930518002644 Powder- free Nitrile Examination GlovesClass I
USK123126MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)2014-06-04
USK132802MOTEX POWDERED NITRILE SURGICAL GLOVES2014-05-21
USK122557MOTEX POWDER-FREE NITRILE SURGICAL GLOVES2013-10-03
BR80495510159Medix Brasil Luva para Procedimento Cirúrgico de Nitrilo Sem PóClass II
BR80808480056Luva Cirúrgica Premium BeCare Série BC 60Class II
BR80201960189PROTETOR ADESIVO PARA FERIDAClass I

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