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Hi-Fortune

China · 苏州 · hi-fortune.en.alibaba.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000035403Unified social credit code 91320583660081133Q

This company holds 17 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Saudi Arabia — 4 overseas markets. EU UDI-DI records ≥4, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
17China registrations
Class I 12Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
≥4UDI-DI device records
Class I 4
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
32listed device types
Class I 26Class II 6Class III 0
plus 51 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class I 5
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered 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 Union1,033 raw hits, 296 excluded, 4 confirmed. Large result set — only the first 300 verified
United States51 registration records, 9 510(k), 0 PMA, 8 excluded
China17 certificates (Class III 0 / II 5 / I 12), as of 2026-09-04
United Kingdom5 confirmed, 3 excluded
Brazil0 confirmed, 4 excluded
Saudi Arabia1 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Kunshan Hi-Fortune Health Products Co., Ltd. · Hi-fortune Health products co.,ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000035403
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91320583660081133Q
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
368
Annual revenue
over RMB 500M
Website
hi-fortune.en.alibaba.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
2007-04-05
Registered capital
CNY 50,000,000
Paid-in capital
CNY 8,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Other manufacturing
Last approval date
2026-04-01
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseGazelle 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

12017
12021 · K201855
22022 · K212503
22024 · K241337
32025 · K244003

FDA listed device types

showing 8 of 32
Device, Anti-Tip, Wheelchair 1Armrest, Wheelchair 1Splint, Hand, And Components 1Lift, Patient, Non-Ac-Powered 1Chair, Adjustable, Mechanical 1Footrest, Wheelchair 1Restraint, Wheelchair, Non-Protective 1Board, Scooter, Prone 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20222191930电动轮椅车Class II
CN苏械注准20212191369电动轮椅车Class II
CN苏械注准20162190134电动轮椅车Class II
CN苏械注准20162150012电动护理床Class II
EU06973852594383Class I
EU06973852594406Class I
EU06973852594420Class I
EU06973852591054Class I
UK37951RollatorClass I
UK12330Electronic liftClass I
UK45678Hydraulic patient liftClass I
USK244003Electrically powered wheelchair2025-03-26
USK243962Electrically Powered Wheelchair2025-02-12
USK243961Electrically Powered Wheelchair2025-02-12
SAME0000001372SFDAA00006Hi-fortune Health products co.,ltd

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