HomeChinaFOCUS & FUSION HEALTHCARE (HANGZHOU) CO., LTD.

FOCUS & FUSION HEALTHCARE (HANGZHOU) CO., LTD.

China · Hangzhou City Zhejiang Province · www.focus-fusion.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000017932Unified social credit code 913301080996808507

This company holds 7 NMPA certificates in China and has registrations in European Union, United Kingdom, Brazil — 3 overseas markets. EU UDI-DI records ≥99, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
7China registrations
Class II 7
as of 2026-09-04
EUEuropean UnionEUDAMED
≥99UDI-DI device records
Class IIa 99
large result set — only the first 300 records were verified, so the real figure is at least this
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 IIa 1Custom-made - Class IIa 1
BRBrazilANVISA
1registered devices
Class II 1
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 Union1,221 raw hits, 201 excluded, 99 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 26 excluded
China7 certificates (Class III 0 / II 7 / I 0), as of 2026-09-04
United Kingdom2 confirmed, 8 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: FOCUS & FUSION HEALTHCARE (HANGZHOU) CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000017932
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
RMS Medical Supplies LTD
Unified social credit code
913301080996808507
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Hangzhou City Zhejiang Province
Social-insurance enrolees
157
Annual revenue
RMB 10–30M
Website
www.focus-fusion.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsUltrasound (POCUS, AI-guided, portable)

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
2014-05-09
Registered capital
CNY 3,716,545
Paid-in capital
CNY 3,716,545
Legal form
Limited liability company
Industry classification
Special-purpose equipment manufacturing
Last approval date
2023-02-14
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.

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20252061426便携式彩色多普勒超声诊断系统Class II
CN浙械注准20252061414便携式彩色多普勒超声诊断系统Class II
CN浙械注准20252061215便携式彩色多普勒超声诊断系统Class II
CN浙械注准20222060208彩色多普勒超声诊断系统Class II
EU06974676311910ULTRASOUND PROBESClass IIa
EU06974676311897ULTRASOUND SCANNERSClass IIa
EU06974676311880ULTRASOUND SCANNERSClass IIa
EU06974676311873ULTRASOUND SCANNERSClass IIa
UK40768ConvexClass IIa
UK40761Cetus 40Custom-made - Class IIa
BR81464759019Sistema de Diagnóstico por UltrassonsClass II

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