HomeChinaJiangsu Zhiyu Medical Instrument Co., Ltd

Jiangsu Zhiyu Medical Instrument Co., Ltd

China · 泰州 · www.zyylqc.com
✓ Record-verifiedregistrations found in 5 marketsUnified social credit code 91321283769147319K

This company holds 19 NMPA certificates in China and has registrations in United States, Taiwan, Australia, Russia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
19China registrations
Class I 7Class II 8Class III 4
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
5listed device types
Class I 2Class II 3Class III 0
plus 4 registration records and 1 510(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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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 Union8 raw hits, 8 excluded, 0 confirmed
United States4 registration records, 1 510(k), 0 PMA, 1 excluded
China19 certificates (Class III 4 / II 8 / I 7), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Manufacturer names merged into this page: JIANGSU ZHIYU MEDICAL INSTRUMENT CO., LTD

Regulatory identity

Unified social credit code
91321283769147319K
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
184
Annual revenue
RMB 100–500M
Website
www.zyylqc.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
2005-01-10
Registered capital
CNY 10,180,000
Paid-in capital
CNY 10,180,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-02-14
Recognitions
Micro and small enterpriseNational High-Tech 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

12023 · K212857

FDA listed device types

Catheter, Irrigation 1Accessory, Surgical Apparel 1Needle, Hypodermic, Single Lumen 1Needle, Acupuncture, Single Use 1Syringe, Piston 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243140009一次性使用无菌注射针Class III
CN国械注准20203140267一次性使用输液器 带针Class III
CN国械注准20173140338一次性使用无菌注射器 带针Class III
CN国械注准20143142373一次性使用输液器 带针Class III
USK212857Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use2023-05-09

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