HomeChinaShenzhen Amydi-med Electrics Tech Co., LTD

Shenzhen Amydi-med Electrics Tech Co., LTD

China · 深圳 · www.amydi-med.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000013201Unified social credit code 91440300691172679P

This company holds 10 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Israel — 6 overseas markets. EU UDI-DI records ≥272, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class I 4Class II 6
as of 2026-09-04
EUEuropean UnionEUDAMED
≥272UDI-DI device records
Class I 233Class IIa 1Class IIb 38
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
6registered device records
Class I 4Class IIb 2
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered 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
2registrations
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 Union831 raw hits, 28 excluded, 272 confirmed. Large result set — only the first 300 verified
United States0 registration records, 1 510(k), 0 PMA
China10 certificates (Class III 0 / II 6 / I 4), as of 2026-09-04
United Kingdom6 confirmed, 2 excluded
Brazil1 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN AMYDI-MED ELECTRICS TECH CO., LTD., · SHENZHEN AMYDI-MED ELECTRONICS TECH CO. LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000013201
EU authorised representative
Umedwings Netherlands B.V.
UK responsible person
Reflex Medical Limited
Unified social credit code
91440300691172679P
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
39
Annual revenue
RMB 50–100M
Website
www.amydi-med.com
Product categories
医用诊察和监护器械手术器械呼吸、麻醉和急救器械

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
2009-06-25
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-03-06
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEInnovative 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

12024 · K240668

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262080200一次性使用除颤电极Class II
CN粤械注准20212070427一次性使用脑电传感器Class II
CN粤械注准20202072146一次性体温探头Class II
CN粤械注准20202072136体温探头Class II
EU06931377245111Disposable ECG electrodeClass I
EU06931377245104Disposable ECG electrodeClass I
EU06931377245098Disposable ECG electrodeClass I
EU06931377245081Disposable ECG electrodeClass I
UK34978Reusable NIBP CuffClass I
UK37326Single Use NIBP CuffClass I
UK44771Adult Defibrillation ElectrodeClass I
USK240668Amydi-med Disposable Non-invasive EEG electrodes2024-03-19
BR82521390001CABO EXTENSOR DE OXIMETRIA SPO2Class I
SAME0000000368SFDAA00002NIBP
SAME0000000368SFDAA00002NIBP

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