HomeChinaChangzhou CareU Medical Instruments Co.,Ltd

Changzhou CareU Medical Instruments Co.,Ltd

China · Changzhou Jiangsu · www.czcareu.cn
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000027623Unified social credit code 91320402MA1Q5KG659

This company holds 15 NMPA certificates in China and has registrations in European Union, United States, Australia, Israel — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
15China registrations
Class I 4Class II 11
as of 2026-09-04
EUEuropean UnionEUDAMED
179UDI-DI device records
Class I 179
USUnited StatesFDA openFDA
9listed device types
Class I 4Class II 5Class III 0
plus 9 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
1active ARTG entries
Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 Union180 raw hits, 1 excluded, 179 confirmed
United States9 registration records, 0 510(k), 0 PMA
China15 certificates (Class III 0 / II 11 / I 4), as of 2026-09-04
Manufacturer names merged into this page: Changzhou CareU Medical Instruments Co., Ltd.

Regulatory identity

EU manufacturer SRN
CN-MF-000027623
EU authorised representative
CMC Medical Devices & Drugs SL
Unified social credit code
91320402MA1Q5KG659
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Changzhou Jiangsu
Social-insurance enrolees
33
Annual revenue
RMB 50–100M
Website
www.czcareu.cn
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
2017-08-29
Registered capital
CNY 10,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Technology promotion and application services
Last approval date
2023-05-22
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SME

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

showing 8 of 9
Collector, Urine, Pediatric, For Indwelling Catheter 1Catheter And Tip, Suction 1Collector, Urine, (And Accessories) For Indwelling Catheter 1Respirator, Surgical 1Tubes, Gastrointestinal (And Accessories) 1Paracentesis Tray 1Applicator, Absorbent Tipped, Sterile 1Accessory, Surgical Apparel 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20242142032一次性使用无菌导尿包Class II
CN苏械注准20242141752一次性使用无菌导尿管Class II
CN苏械注准20242141481一次性使用无菌手术包Class II
CN苏械注准20242141475一次性使用无菌换药包Class II
EU06972992510475Disposable urinary drainage bagClass I
EU06972992510819Disposable urinary drainage bagClass I
EU06972992513063Disposable E你teral Feeding setsClass I
EU06972992513056Disposable E你teral Feeding setsClass I

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