HomeChinaSHANDONG FENGAO MEDICAL TECHNOLOGY CO., LTD.

SHANDONG FENGAO MEDICAL TECHNOLOGY CO., LTD.

China · Zibo Shandong · www.fengaomedical.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000026217Unified social credit code 91370303MA3C03U53H

This company holds 24 NMPA certificates in China and has registrations in European Union, United States, Brazil — 3 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
24China registrations
Class I 19Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 300
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
3listed device types
Class I 3Class II 0Class III 0
plus 3 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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 Union551 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States3 registration records, 0 510(k), 0 PMA
China24 certificates (Class III 0 / II 5 / I 19), as of 2026-09-04
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: SHANDONG FENGAO MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000026217
EU authorised representative
Kingsmead Service B.V.
Unified social credit code
91370303MA3C03U53H
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Zibo Shandong
Social-insurance enrolees
59
Annual revenue
RMB 30–50M
Website
www.fengaomedical.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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
2015-11-13
Registered capital
CNY 5,000,000
Paid-in capital
CNY 3,910,000
Legal form
Limited liability company (wholly owned by a natural person)
Industry classification
Pharmaceutical manufacturing
Last approval date
2024-04-25
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

Tape And Bandage, Adhesive 1Device, Intravascular Catheter Securement 1Dressing, Wound, Occlusive 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20262140140导管固定装置Class II
CN鲁械注准20252140482一次性使用中心静脉置管护理套件Class II
CN鲁械注准20252140126一次性使用护理包Class II
CN鲁械注准20232141045一次性使用无菌手术膜Class II
EU06970670812361Surgical TapeClass I
EU06970670810138Surgical TapeClass I
EU06970670812507Surgical TapeClass I
EU06970670811906Surgical TapeClass I
BR80670160101DRAPIXClass I
BR81840540002FILME TRANSPARENTE ROLO PUClass I

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