HomeChinaHuaian Youwen Medical Technology Co., Ltd.

Huaian Youwen Medical Technology Co., Ltd.

China · Huaian City Jiangsu Province · www.huaianyouwen.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000049185Unified social credit code 91320829MA1R8P1011

This company holds 3 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
3China registrations
Class I 3
as of 2026-09-01
EUEuropean UnionEUDAMED
3UDI-DI device records
Class I 3
USUnited StatesFDA openFDA
6listed device types
Class I 2Class II 4Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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 Union52 raw hits, 49 excluded, 3 confirmed
United States5 registration records, 0 510(k), 0 PMA, 1 excluded
China3 certificates (Class III 0 / II 0 / I 3), as of 2026-09-01
United Kingdom0 confirmed, 1 excluded
Manufacturer names merged into this page: HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000049185
EU authorised representative
SUNGO Europe B.V.
Unified social credit code
91320829MA1R8P1011
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Huaian City Jiangsu Province
Social-insurance enrolees
36
Annual revenue
under RMB 5M
Website
www.huaianyouwen.com
Product categories
Integrated Care, Rehabilitation & HomecareHomecare, long-term care & ageing

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
2017-09-28
Registered capital
CNY 6,000,000
Paid-in capital
CNY 6,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-06-08
Recognitions
Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-01. 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

Pack, Hot Or Cold, Water Circulating 1Mattress, Air Flotation, Alternating Pressure 1Sleeve, Limb, Compressible 1Massager, Powered Inflatable Tube 1Pack, Hot Or Cold, Disposable 1Pack, Hot Or Cold, Reusable 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏淮械备20250018压力腿套Class I · 2025-04-03
CN苏淮械备20240079防褥疮垫Class I
CN苏淮械备20250019肢体压力套Class I
EU06973261210355Class I
EU06973261210164Class I
EU06973261210003Class I

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