HomeChinaShandong Kangli Medical Equipment Technology Co., Ltd

Shandong Kangli Medical Equipment Technology Co., Ltd

China · 枣庄 · www.sdkangli.com
✓ Record-verifiedregistrations found in 2 marketsUnified social credit code 91370400727541190A

This company holds 75 NMPA certificates in China and has registrations in United States — 1 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
75China registrations
Class I 30Class II 37Class III 6
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
23listed device types
Class I 20Class II 3Class III 0
plus 23 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
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 Union1,063 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States23 registration records, 1 510(k), 0 PMA, 2 excluded
China75 certificates (Class III 6 / II 37 / I 30), as of 2026-09-04
Manufacturer names merged into this page: SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.

Regulatory identity

Unified social credit code
91370400727541190A
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
273
Annual revenue
RMB 30–50M
Website
www.sdkangli.com
Product categories
医用耗材手术室及急救患者承载器械口腔妇产及生殖

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
2001-02-28
Registered capital
CNY 36,361,100
Paid-in capital
CNY 36,361,100
Legal form
Limited liability company (state-controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-06-08
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI SMEGazelle 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

12020 · K192560

FDA listed device types

showing 8 of 23
Cap, Surgical 1Forceps 1Gauze / Sponge,Nonresorbable For External Use 1Bag, Stomal 1Protector, Ostomy 1Bedding, Disposable, Medical 1Dressing, Wound, Occlusive 1Closure, Wound, Adhesive 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243141187一次性使用输液器 带针Class III
CN国械注准20243140781一次性使用精密过滤输液器 带针Class III
CN国械注准20193081614一次性使用麻醉穿刺包Class III
CN国械注准20173144698一次性精密过滤输液器 带针Class III
USK192560Surgical Gown2020-05-22

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