HomeUSASolaris Medical Technology, Inc.

Solaris Medical Technology, Inc.

USA · San Francisco CA · www.solarismedtech.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000038492Unified social credit code 914403007488778140

This company holds 10 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Canada, Taiwan, Singapore — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class I 6Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
181UDI-DI device records
Class I 82Class IIb 99
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 4 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class I 3Class IIb 2
BRBrazilANVISA
0registered devices
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
4active device licences
Class II 4
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
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 Union181 raw hits, 0 excluded, 181 confirmed
United States4 registration records, 5 510(k), 0 PMA
China10 certificates (Class III 0 / II 2 / I 6), as of 2026-09-04
United Kingdom5 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: SOLARIS MEDICAL TECHNOLOGY, INC.

Regulatory identity

EU manufacturer SRN
CN-MF-000038492
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Advena Ltd
Unified social credit code
914403007488778140
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
USA
City
San Francisco CA
Social-insurance enrolees
62
Annual revenue
RMB 50–100M
Website
www.solarismedtech.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentAnaesthesia, intensive care & life-support systems

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
2003-04-17
Registered capital
CNY 5,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company (Sino-foreign joint venture)
Industry classification
Instruments and meters manufacturing
Last approval date
2022-07-28
Recognitions
Micro and small enterprise

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

12007 · K061931
12008 · K073249
32010 · K100077

FDA listed device types

Blood Pressure Cuff 1Cable, Electrode 1Oximeter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262070581血氧探头Class II
CN粤械注准20162071477一次性血氧探头Class II
CN粤莞械备20220031血压袖带Class I · 2022-10-09
CN粤深械备20250484血压袖带Class I
EU06900234306197Disposable NIBP CuffClass I
EU06900234101303Reusable SpO2 sensorsClass IIb
EU06900234101709Reusable SpO2 sensorsClass IIb
EU06900234103727Reusable SpO2 sensorsClass IIb
UK34978REUSABLE & DISPOSABLE BLOOD PRESSUE CUFFSClass I
UK37326REUSABLE & DISPOSABLE BLOOD PRESSUE CUFFSClass I
UK47487SPO2 ADAPTING CABLESClass I
USK100077NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-0901032010-10-07
USK101972SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS2010-07-22
USK092950SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES2010-03-12
CA96959DISPOSABLE SPO2 SENSORSClass II
CA96960DISPOSABLE NON-INVASIVE BLOOD PRESSURE CUFFSClass II
CA96966REUSABLE NON-INVASIVE BLOOD PRESSURE CUFFSClass II

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