HomeChinaSonosemi Medical Co., Ltd.

Sonosemi Medical Co., Ltd.

China · 深圳 · www.sonosemi.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000042188Unified social credit code 91440300MA5G4JRKX6

This company holds 10 NMPA certificates in China and has registrations in European Union, United Kingdom, Brazil, Singapore, South Korea, Australia, Hong Kong — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class III 10
as of 2026-09-04
EUEuropean UnionEUDAMED
7UDI-DI device records
Class III 7
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIb 1Class III 1
BRBrazilANVISA
0registered devices
2 including historic records
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
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
Class III 1IIb 1
HKHong KongMDACS
1valid listings
Class IV 1
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 Union7 raw hits, 0 excluded, 7 confirmed
China10 certificates (Class III 10 / II 0 / I 0), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Manufacturer names merged into this page: SONOSEMI MEDICAL CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000042188
EU authorised representative
PureCE B.V.
UK responsible person
OscarTech Uk Ltd
Unified social credit code
91440300MA5G4JRKX6
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
144
Website
www.sonosemi.com
Product categories
手术器械医用成像器械

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
2020-04-08
Registered capital
CNY 5,097,016
Paid-in capital
CNY 4,402,339
Legal form
Limited liability company
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-06-09
Recognitions
National 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263030010冠脉刻痕球囊扩张导管Class III
CN国械注准20263011815一次性使用冠脉血管内冲击波导管Class III
CN国械注准20253062205血管内超声诊断设备Class III
CN国械注准20253062176一次性使用冠脉血管内超声诊断导管Class III
EU06974215910079LiqMagic C14Class III
EU06974215910062LiqMagic C14Class III
EU06974215910055LiqMagic C14Class III
EU06974215910048LiqMagic C14Class III
UK66728LiqMagic® Class III
UK66730Intravascular Lithotripsy GeneratorClass IIb

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