HomeChinaJIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD

JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD

China · 苏州 · www.redleaf.cn
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000008761Unified social credit code 91320582608261137H

This company holds 47 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Saudi Arabia, Taiwan, Australia, Russia — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
47China registrations
Class I 36Class II 11
as of 2026-09-04
EUEuropean UnionEUDAMED
167UDI-DI device records
Class I 167
USUnited StatesFDA openFDA
7listed device types
Class I 6Class II 1Class III 0
plus 7 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
10registered device records
Class I 10
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
8registered 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
6active ARTG entries
Class I 6
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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 Union167 raw hits, 0 excluded, 167 confirmed
United States7 registration records, 0 510(k), 0 PMA
China47 certificates (Class III 0 / II 11 / I 36), as of 2026-09-04
United Kingdom10 confirmed, 0 excluded
Saudi Arabia8 confirmed, 1 excluded
Manufacturer names merged into this page: JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD · JIANGSU RIXIN MEDICAL EQUIPMENT CO.,LTD · Jiangsu Rixin Medical Equipment Co., Ltd.

Regulatory identity

EU manufacturer SRN
CN-MF-000008761
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91320582608261137H
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
112
Annual revenue
RMB 100–500M
Website
www.redleaf.cn

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
1994-06-22
Registered capital
CNY 15,000,000
Paid-in capital
CNY 15,000,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-07-21
Recognitions
Micro and small enterpriseNational High-Tech EnterprisePrivate technology enterpriseSRDI SMEGazelle enterpriseAbove-designated-size industrial enterprise
Listing
Delisted from the NEEQ

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

Stretcher, Hand-Carried 1Board, Cardiopulmonary 1Stand, Infusion 1Support, Patient Position 1Stretcher, Patient Restraint 1Depressor, Tongue, Non-Surgical 1Stretcher, Wheeled 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20262091060空气波压力治疗仪Class II
CN苏械注准20222200872中药熏蒸器Class II
CN苏械注准20222140829便携式电动吸引器Class II
CN苏械注准20202201601中药熏蒸治疗仪Class II
EU06974442050074Class I
EU06974442050043Class I
EU06974442050708Class I
EU06974442050036Class I
UK35843Stretcher for ambulance carClass I
UK41039Cervical collarClass I
UK64250SplintClass I
SAME0000007962SFDAA00001Medical External Fixation Splint
SAME0000010655SFDAA00002HEAD IMMOBILIZE

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