HomeChinaShenzhen Konmed Technology Co. Ltd

Shenzhen Konmed Technology Co. Ltd

China · 深圳 · www.konmed.cn
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000018375Unified social credit code 91440300077540355R

This company holds 3 NMPA certificates in China and has registrations in European Union, United States, Brazil, Canada — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
3China registrations
Class II 3
as of 2026-09-04
EUEuropean UnionEUDAMED
8UDI-DI device records
Class I 2Class IIa 6
USUnited StatesFDA openFDA
8listed device types
Class I 1Class II 7Class III 0
plus 10 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
2registered devices
Class II 2
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
2 including historic records
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 Union8 raw hits, 0 excluded, 8 confirmed
United States10 registration records, 7 510(k), 0 PMA
China3 certificates (Class III 0 / II 3 / I 0), as of 2026-09-04
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN KONMED TECHNOLOGY CO., LTD · SHENZHEN KONMED TECHNOLOGY CO., LTD. · Shenzhen Konmed Technology Co., Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000018375
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91440300077540355R
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
21
Annual revenue
RMB 10–30M
Website
www.konmed.cn
Product categories
物理治疗器械家用器械医用康复器械

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
2013-08-29
Registered capital
CNY 2,000,000
Paid-in capital
CNY 2,000,000
Legal form
Limited liability company
Industry classification
Computer, communications and other electronic equipment
Last approval date
2023-03-01
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

32018 · K163288
12020 · K202648
12022 · K220161
12024 · K233576
12026 · K260178

FDA listed device types

Stimulator, Muscle, Powered 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Cable, Electrode 1Electrode, Cutaneous 1Perineometer 1Vibrator For Therapeutic Use, Genital 1Device, Biofeedback 1Mouthpiece, Breathing 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20242090705生物反馈电刺激治疗仪Class II
CN粤械注准20212091098生物反馈及电刺激治疗仪Class II
CN粤械注准20172091070低频电子脉冲治疗仪Class II
EU06970935830772Multifunctional stimulator Class IIa
EU06970935830543Biofeedback nerve and muscle stimulatorClass IIa
EU06970935830536Biofeedback Nerve and Muscle StimulatorClass IIa
EU06970935830499ProbeClass IIa
USK260178Pelvic Muscle Trainer (KM510, KM516B)2026-06-18
USK233576Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)2024-02-23
USK220161Biofeedback Nerve and Muscle Stimulator2022-07-20
BR80786940006ELETRODOS AUTO ADESIVOS ALEPH ELECTRODES PREMIUM LINEClass II
BR80786940007ELETRODOS DE TECIDO ALEPH ELECTRODES PREMIUM LINEClass II

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