HomeChinaJiangsu Kehua Medical Instrument Technology Co.,Ltd

Jiangsu Kehua Medical Instrument Technology Co.,Ltd

China · 盐城 · www.jskehua.cn
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000028654Unified social credit code 913209817307172571

This company holds 9 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
9China registrations
Class I 9
as of 2026-09-04
EUEuropean UnionEUDAMED
83UDI-DI device records
IVD A 83
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 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 Union235 raw hits, 152 excluded, 83 confirmed
United States1 registration records, 0 510(k), 0 PMA, 1 excluded
China9 certificates (Class III 0 / II 0 / I 9), as of 2026-09-04
Brazil0 confirmed, 3 excluded
Manufacturer names merged into this page: JIANGSU KEHUA MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000028654
EU authorised representative
Sungo Cert GmbH
Unified social credit code
913209817307172571
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
75
Annual revenue
RMB 100–500M
Website
www.jskehua.cn
Product categories
体外诊断

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
2001-08-21
Registered capital
CNY 10,800,000
Paid-in capital
CNY 5,005,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-11-17
Recognitions
National High-Tech EnterprisePrivate technology enterpriseSRDI SMEGazelle enterpriseRecognised enterprise technology centreAbove-designated-size industrial 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

Micro Pipette 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏盐械备20250050待测物清洗液Class I
CN苏盐械备20230041一次性使用尿液采集器Class I
CN苏盐械备20200053号毛细玻璃采血吸管Class I
CN苏盐械备20200050号毛细塑料采血吸管Class I
EU06970952649500IVD A
EU06970952640552IVD A
EU06970952640545IVD A
EU06970952640538IVD A

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →