HomeChinaFOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY (LTD.)

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY (LTD.)

China · Foshan Guangdong · www.fsdfmed.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000036028Unified social credit code 914406007081787952

This company holds 14 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
14China registrations
Class I 10Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
82UDI-DI device records
Class I 82
USUnited StatesFDA openFDA
14listed device types
Class I 13Class II 1Class III 0
plus 14 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class I 2
BRBrazilANVISA
19registered devices
Class I 19
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
73registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
21active registrations
Class 1 14Class 2a 7
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 Union264 raw hits, 182 excluded, 82 confirmed
United States14 registration records, 1 510(k), 0 PMA, 1 excluded
China14 certificates (Class III 0 / II 4 / I 10), as of 2026-09-04
United Kingdom2 confirmed, 2 excluded
Brazil19 confirmed, 2 excluded
Saudi Arabia73 confirmed, 0 excluded
Manufacturer names merged into this page: FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY(LTD) · FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY (LTD.) · FOSHAN DONGFANG MEDICAL EQUIPAMENT MANUFACTORY (LTD.) · FOSHAN DONGFANG MEDICAL EQUIPMENT FACTORY LTD · FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY(LTD.) · Foshan Dongfang Medical Equipment Manufactory LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000036028
EU authorised representative
MedNet EC-REP GmbH
UK responsible person
Medimap Ltd
Unified social credit code
914406007081787952
Exhibition record
Rehab & Elderly Care Expo (Spring 2024, Shanghai) · Rehab & Elderly Care Expo (Spring 2026, Shanghai)

Company information

Country
China
City
Foshan Guangdong
Social-insurance enrolees
184
Annual revenue
RMB 100–500M
Website
www.fsdfmed.com
Product categories
Healthcare Infrastructure, Manufacturing & QualityManufacturing, CDMO & industrial medtech

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
1999-02-12
Registered capital
CNY 12,880,000
Paid-in capital
CNY 772,800
Legal form
Limited liability company (HK/Macao/Taiwan invested, not wholly owned, not wholly owned)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-04-07
Recognitions
National High-Tech EnterpriseSRDI SMEInnovative SME

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

12004 · K041814

FDA listed device types

showing 8 of 14
Attachment, Commode, Wheelchair 1Wheelchair, Mechanical 1Table, Mechanical 1Stand, Infusion 1Adaptor, Hygiene 1Mattress, Flotation Therapy, Non-Powered 1Chair And Table, Medical 1Lift, Patient, Non-Ac-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20192190903电动轮椅车Class II
CN粤械注准20172190451手动轮椅车Class II
CN粤械注准20172190057手动轮椅车Class II
CN粤械注准20172150268医用电动病床Class II
EU06938001011067Class I
EU06938001012361Class I
EU06938001011142Class I
EU06938001021790Class I
UK41875POWERED WHEELCHAIRClass I
UK41512MANUAL WHEELCHAIRClass I
USK041814FS SERIES WHEELCHAIR2004-07-20
BR82255340009Cadeira de Rodas de Banho HigiênicaClass I
BR82255340010Cadeira de Rodas Manual WinnerMedClass I
BR82255340005Andador para Idoso 4 rodas Winner MedClass I
SAME0000000149SFDAA00001Manual Wheelchair
SAME0000000149SFDAA00007Walking

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