HomeChinaJiangsu Ostup Medical Products Co.,Ltd

Jiangsu Ostup Medical Products Co.,Ltd

China · 南京 · www.ostupmedical.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000040133Unified social credit code 913201163027277156

This company holds 18 NMPA certificates in China and has registrations in European Union, United States, Brazil, Saudi Arabia, Russia — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
18China registrations
Class I 13Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
21UDI-DI device records
Class IIa 21
USUnited StatesFDA openFDA
10listed device types
Class I 9Class II 1Class III 0
plus 10 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
3registered devices
Class I 3
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered 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
1active registrations
Class 1 1
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 Union21 raw hits, 0 excluded, 21 confirmed
United States10 registration records, 0 510(k), 0 PMA
China18 certificates (Class III 0 / II 5 / I 13), as of 2026-09-04
Brazil3 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: JIANGSU OSTUP MEDICAL PRODUCTS CO. LTD. · JIANGSU OSTUP MEDICAL PRODUCTS CO., LTD · Jiangsu Ostup Medical Products Co.,Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000040133
EU authorised representative
Prolinx GmbH
Unified social credit code
913201163027277156
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
36
Annual revenue
under RMB 5M
Website
www.ostupmedical.com
Product categories
医用耗材

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
2015-04-02
Registered capital
CNY 20,000,000
Paid-in capital
CNY 6,397,400
Legal form
Limited liability company (wholly owned by a natural person)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-06-12
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 listed device types

showing 8 of 10
Bag, Urine Collecting, Ureterostomy 1Device, Fixation, Tracheal Tube 1Protector, Ostomy 1Bag, Urine Collection, Leg, For External Use, Non-Sterile 1Collector, Ostomy 1Dressing, Wound, Hydrophilic 1Tape And Bandage, Adhesive 1Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20252141051水凝胶敷料Class II
CN苏械注准20232060372一次性使用内窥镜取物袋Class II
CN苏械注准20222140962藻酸盐敷料Class II
CN苏械注准20212141418聚氨酯泡沫敷料Class II
EU06970944383276Class IIa
EU06970944383269Class IIa
EU06970944383252Class IIa
EU06970944383245Class IIa
BR80876020003BOLSA DE OSTOMIAClass I
BR80876020004BOLSA DE UROSTOMIAClass I
BR80876020005PLACA DE OSTOMIAClass I
SAME0000002967SFDAA00012OstupMed

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