HomeChinaYangzhou Super Union Medical Material Co., ltd

Yangzhou Super Union Medical Material Co., ltd

China · 扬州 · www.sumed.com.cn
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000010954

This company holds 6 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 8 overseas markets. EU UDI-DI records ≥5, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
6China registrations
Class I 3Class II 3
as of 2026-09-04
EUEuropean UnionEUDAMED
≥5UDI-DI device records
Class I 5
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
8listed device types
Class I 8Class II 0Class III 0
plus 9 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class I 1
BRBrazilANVISA
5registered devices
Class I 3Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
146registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
8valid device licences
Class I 8
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 2IIa 1IIb 1Class Is (sterile) 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
9registrations
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 Union6,731 raw hits, 95 excluded, 5 confirmed. Large result set — only the first 300 verified
United States9 registration records, 0 510(k), 0 PMA, 15 excluded
China6 certificates (Class III 0 / II 3 / I 3), as of 2026-09-04
United Kingdom1 confirmed, 14 excluded
Brazil5 confirmed, 5 excluded
Saudi Arabia146 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: YANGZHOU SUPER J TOOTHBRUSH CO.,LTD. · YANGZHOU SUPER UNION MEDICAL MATERIAL CO. · YANGZHOU SUPER UNION IMPORT & EXPORT CO., LTD · YANGZHOU SUPER UNION MEDICAL MATERIAL CO. LTD · YANGZHOU SUPER UNION IMPORT&EXPORT CO., LTD. · Yangzhou Super Union Import and Export Co. Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000010954
EU authorised representative
SUNGO Europe B.V.
UK responsible person
Euverify Ltd
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
120
Website
www.sumed.com.cn
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
2003-12-05
Registered capital
CNY 25,000,000
Paid-in capital
CNY 11,080,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2023-05-19
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMERecognised enterprise technology centreInnovative SMEAbove-designated-size industrial 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

Toothbrush, Powered 1Dental Hygiene Kit 1Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile 1Floss, Dental 1Applicator, Absorbent Tipped, Non-Sterile 1Toothbrush, Manual 1Unit, Oral Irrigation 1Scraper, Tongue 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20192140800医用纱布巾Class II
CN苏械注准20192140799医用纱布片Class II
CN苏械注准20192140798医用无纺布片Class II
CN苏扬械备20200424号隔离衣Class I
EU06974265596537Class I
EU06974265596353Class I
EU06974265595851Class I
EU06974265595967Class I
UK34864PosiPulse Assorted Adhesive Wound Dressings (Sterile)Class I
BR81771620002MASCARA DESCARTÁVEL SIMPLECAREClass I
BR81434510005Avental Cirúrgico Estéril DescartávelClass I
BR82834410001Torneira 3 viasClass I
SAME0000009370SFDAA00012SUGAMA
SAME0000009370SFDAA00011Hygiene Adhesive eye pad plaster

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