HomeChinaURIT MEDICAL ELECTRONIC CO.,LTD.

URIT MEDICAL ELECTRONIC CO.,LTD.

China · Guilin Guangxi · www.urit.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000011840Unified social credit code 91450300742099433G

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, South Korea, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥97, the first 300 verified individually. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
≥97UDI-DI device records
IVD A 15IVD B 15IVD general 62ivd-annex-ii-list-b 2ivd-devices-self-testing 3
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
28listed device types
Class I 23Class II 5Class III 0
plus 16 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
15registered device records
Class I 2Class IIa 1IVD A 5IVD general 5IVD Devices for Self-Testing 2
BRBrazilANVISA
66registered devices
Class I 10Class II 56
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
IVD import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
RURussiaRoszdravnadzor
72active registrations
Class 1 1Class 2a 71
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 Union1,024 raw hits, 103 excluded, 97 confirmed. Large result set — only the first 300 verified
United States16 registration records, 2 510(k), 0 PMA
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
United Kingdom15 confirmed, 3 excluded
Brazil66 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: URIT Medical Electronic Co., Ltd. · URIT MEDICAL ELECTRONIC CO LTD · URIT MEDICAL ELETRONIC CO., LTD · URIT Medical Electronic Co.,Ltd · URIT MEDICAL ELECTRONIC CO.,LTD · URIT Medical Electronic Co., Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000011840
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Wellkang Ltd
Unified social credit code
91450300742099433G
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
City
Guilin Guangxi
Social-insurance enrolees
334
Annual revenue
over RMB 500M
Website
www.urit.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsHematology & coagulation

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
2002-11-20
Registered capital
CNY 15,900,000
Paid-in capital
CNY 15,900,000
Legal form
Limited liability company
Industry classification
Wholesale trade
Last approval date
2026-01-30
Recognitions
Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-03. 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

12009 · K082811
12024 · K232317

FDA listed device types

showing 8 of 28
Hydrazone Colorimetry, Alt/Sgpt 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Ldl & Vldl Precipitation, Hdl 1Refractometer For Clinical Use 1Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) 1Colorimetric Method, Triglycerides 1Automated Urinalysis System 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06935740753678IVD B
EU06935740753791IVD A
EU06935740753784IVD B
EU06935740753777IVD B
UK61165LyseIVD A
UK58237DiluentIVD A
UK35775LED Light Curing DeviceClass I
USK232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips2024-04-26
USK082811URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS2009-09-11
BR80223480096Família de Sistemas de Urinálise AI-LibreClass II
BR80223480035AUTOMATED HEMATOLOGY ANALYZER,URIT-3000PLUSClass II
BR80223480034AUTOMATIC CHEMISTRY ANALYZERClass II
SAME0000002043SFDAA00010VRN

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