HomeChinaZhuhai Linte Medical Instrument Co., Ltd.

Zhuhai Linte Medical Instrument Co., Ltd.

China · 珠海 · www.lintemed.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000012803Unified social credit code 91440400MA4X85TW8M

This company holds 10 NMPA certificates in China and has registrations in European Union, United States, Brazil — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class II 10
as of 2026-09-04
EUEuropean UnionEUDAMED
11UDI-DI device records
Class IIa 9Class IIb 2
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
7registered devices
Class II 7
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 Union23 raw hits, 12 excluded, 11 confirmed
United States3 registration records, 2 510(k), 0 PMA
China10 certificates (Class III 0 / II 10 / I 0), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000012803
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91440400MA4X85TW8M
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
53
Annual revenue
RMB 100–500M
Website
www.lintemed.com
Product categories
呼吸、麻醉和急救器械医用诊察和监护器械

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
2017-10-19
Registered capital
CNY 49,000,000
Paid-in capital
CNY 49,000,000
Legal form
Limited liability company
Industry classification
Instruments and meters manufacturing
Last approval date
2025-06-20
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative 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

12021 · K210274
12022 · K220220

FDA listed device types

System, Measurement, Blood-Pressure, Non-Invasive 1Oximeter, Infrared, Sporting, Aviation 1Oximeter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262070529臂式电子血压计Class II
CN粤械注准20222180379超声多普勒胎儿心率仪Class II
CN粤械注准20222180308超声多普勒胎儿心率仪Class II
CN粤械注准20222080400医用压缩式雾化器Class II
EU06972887880072Multi-patameter moniterClass IIb
EU06972887880065Multi-patameter moniterClass IIb
EU06972887880041NebulizerClass IIa
EU06972887880119NebulizerClass IIa
USK220220Electronic Sphygmomanometer (Model: LT-P30)2022-10-03
USK210274Fingertip Pulse Oximeter2021-07-30
BR81602809013LT-N100 - NebulizadorClass II
BR80499949007Oximetro de Pulso de Dedo Red CareClass II
BR10343209045OXÍMETROClass II

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