HomeChinaShenzhen Sino-K Medical Tech Co.,Ltd Co., Ltd.

Shenzhen Sino-K Medical Tech Co.,Ltd Co., Ltd.

China · Shenzhen Guangdong · www.sino-k.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000021157Unified social credit code 91440300MA5DKYQL7G

This company holds 9 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Australia — 4 overseas markets. EU UDI-DI records ≥5, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
9China registrations
Class I 4Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
≥5UDI-DI device records
Class I 5
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
4listed device types
Class I 0Class II 4Class III 0
plus 4 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class I 2Class IIa 1Class IIb 1
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
2active ARTG entries
Class I 1IIb 1
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 Union1,882 raw hits, 295 excluded, 5 confirmed. Large result set — only the first 300 verified
United States4 registration records, 3 510(k), 0 PMA, 17 excluded
China9 certificates (Class III 0 / II 5 / I 4), as of 2026-09-04
United Kingdom4 confirmed, 10 excluded
Brazil0 confirmed, 4 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000021157
EU authorised representative
Prolinx GmbH
UK responsible person
PROLINX GLOBAL LTD
Unified social credit code
91440300MA5DKYQL7G
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Shenzhen Guangdong
Social-insurance enrolees
59
Annual revenue
RMB 30–50M
Website
www.sino-k.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentAnaesthesia, intensive care & life-support systems

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
2016-09-13
Registered capital
CNY 8,000,000
Paid-in capital
CNY 3,944,300
Legal form
Limited liability company
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-03-26
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based 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 510(k) clearances by year

12020 · K192608
22023 · K231961

FDA listed device types

Continuous Measurement Thermometer 1Blood Pressure Cuff 1Cable, Electrode 1Oximeter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20252071688一次性体温传感器Class II
CN粤械注准20252071566重复性心电电极Class II
CN粤械注准20252071545体温传感器Class II
CN粤械注准20202071633重复性血氧探头Class II
EU06972820968805SB0223Class I
EU06942108021928SB0423Class I
EU06972820967358SB0523Class I
EU06942108021911IBP CableClass I
UK34978NIBP CuffClass I
UK35562Patient Cable and LeadwiresClass I
UK37340Temperature ProbeClass IIa
USK231961NIBPCuff2023-08-30
USK223807Reusable Temperature Probe, Disposable Temperature Probe2023-08-25
USK192608Disposable SpO2 Sensor2020-01-24

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