HomeChinaGUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD.

GUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD.

China · 广州 · www.fuzelong.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000023141Unified social credit code 914401847837984924

This company holds 28 NMPA certificates in China and has registrations in European Union, United States, Brazil, Taiwan, Australia, Israel — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
28China registrations
Class I 17Class II 11
as of 2026-09-04
EUEuropean UnionEUDAMED
84UDI-DI device records
Class I 84
USUnited StatesFDA openFDA
17listed device types
Class I 14Class II 3Class III 0
plus 19 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
8registered devices
Class I 8
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 Union84 raw hits, 0 excluded, 84 confirmed
United States19 registration records, 2 510(k), 0 PMA
China28 certificates (Class III 0 / II 11 / I 17), as of 2026-09-04
Brazil8 confirmed, 0 excluded
Manufacturer names merged into this page: GUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD. · GUANGZHOU FUZELONG HYGIENE MATERIAL CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000023141
EU authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Unified social credit code
914401847837984924
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
90
Annual revenue
RMB 50–100M
Website
www.fuzelong.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
2006-03-01
Registered capital
CNY 50,000,000
Paid-in capital
CNY 50,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Chemical fibre manufacturing
Last approval date
2021-04-27
Recognitions
Micro and small enterpriseInnovative 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 510(k) clearances by year

22023 · K222545

FDA listed device types

showing 8 of 17
Cap, Surgical 1Drape, Adhesive, Aerosol 1Gauze / Sponge,Nonresorbable For External Use 1Accessory, Surgical Apparel 1Bag, Ice 1Gown, Examination 1Non-Surgical Gown 1Mask, Scavenging 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20232140030一次性使用无菌产包Class II
CN粤械注准20232140029一次性使用无菌介入手术包Class II
CN粤械注准20232140027一次性使用无菌手术包Class II
CN粤械注准20232140026一次性使用无菌眼科包Class II
EU06921825704529HY MEDICALClass I
EU06921825704512HY MEDICALClass I
EU06921825704505PUYUANClass I
EU06921825704567Class I
USK222545Disposable Medical Mask2023-05-19
USK222403Surgical Gown2023-01-26
BR80201960096AVENTAL/JALECO/CAPOTE DESCARTÁVEL SMS COM PROTEÇÃO IMPERMEÁVEL WINNERClass I
BR80201960089PROPÉ/SAPATILHA DESCARTÁVEL WINNERClass I
BR80201960090TOUCA/TURBANTE/GORRO DESCARTÁVEL WINNERClass I

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