HomeChinaWUHAN ZONSEN INTERNATIONAL CO.,LTD

WUHAN ZONSEN INTERNATIONAL CO.,LTD

China · 武汉 · www.zonsengroup.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000008034Unified social credit code 91420117MA4KX4C93H

This company has registrations in European Union, United States, United Kingdom, Brazil — 4 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
76UDI-DI device records
Class I 76
USUnited StatesFDA openFDA
24listed device types
Class I 17Class II 5Class III 0unclassified 2
plus 48 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
8registered device records
Class I 8
BRBrazilANVISA
2registered devices
Class I 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
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 Union76 raw hits, 0 excluded, 76 confirmed
United States48 registration records, 6 510(k), 0 PMA
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
United Kingdom8 confirmed, 0 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD · WUHAN ZONSEN INTERNATIONAL CO., LTD
Same-named companies — This database also contains companies with near-identical names: Wuhan Zonsen Medical Products Co.,Ltd. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

EU manufacturer SRN
CN-MF-000008034
EU authorised representative
Lotus NL B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91420117MA4KX4C93H
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
27
Annual revenue
RMB 100–500M
Website
www.zonsengroup.com
Product categories
注输、护理和防护器械医用耗材

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
2017-11-22
Registered capital
CNY 5,000,000
Paid-in capital
CNY 1,000,000
Legal form
Limited liability company (wholly owned by a natural-person-controlled corporation)
Industry classification
Wholesale trade
Last approval date
2025-09-01
Recognitions
Micro and small enterprise

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

22021 · K212861
32022 · K213601
12023 · K223600

FDA listed device types

showing 8 of 24
Cap, Surgical 1Pad, Menstrual, Unscented 1Component, Cast 1Accessory, Surgical Apparel 1Brush, Scrub, Operating-Room 1Gown, Examination 1Cotton, Roll 1Non-Surgical Gown 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06976128166628EMDAMEDClass I
EU06976128166895homedcare,undercollar gownClass I
EU06976128165843homedcare,blue cover,non-sterileClass I
EU06976128164778homedcare,blue cover,non-sterileClass I
UK35492CPE gownClass I
UK58415Scrub suitClass I
UK15056Shoe coverClass I
USK223600Sterilization Wrap2023-08-25
USK213601Surgical Mask2022-12-16
USK213688Nitrile Examination Gloves (Model: ZMG1351)2022-02-18
BR8003400131AVENTAL DESCARTÁVEL POLAR FIXClass I
BR8003400127AVENTAL CIRÚRGICO ESTÉRIL POLAR FIXClass I

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