HomeChinaGUANGDONG GENIAL TECHNOLOGY CO., LIMITED

GUANGDONG GENIAL TECHNOLOGY CO., LIMITED

China · Zhaoqing Guangdong Province · www.genial.cn
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000021465Unified social credit code 91440101728221498C

This company holds 11 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, South Korea, Australia, Israel, Russia — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
11China registrations
Class I 1Class II 10
as of 2026-09-04
EUEuropean UnionEUDAMED
81UDI-DI device records
Class IIa 81
USUnited StatesFDA openFDA
5listed device types
Class I 1Class II 4Class III 0
plus 7 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
9registered device records
Class IIa 9
BRBrazilANVISA
6registered devices
Class II 6
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
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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 Union81 raw hits, 0 excluded, 81 confirmed
United States7 registration records, 6 510(k), 0 PMA, 2 excluded
China11 certificates (Class III 0 / II 10 / I 1), as of 2026-09-04
United Kingdom9 confirmed, 0 excluded
Brazil6 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: GUANGDONG GENIAL TECHNOLOGY CO., LTD. · GUANGDONG GENIAL TECHNOLOGY CO., LIMITED

Regulatory identity

EU manufacturer SRN
CN-MF-000021465
EU authorised representative
MedPath GmbH
UK responsible person
ABMED MEDICAL TECHNOLOGY GROUP LTD
Unified social credit code
91440101728221498C
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Zhaoqing Guangdong Province
Social-insurance enrolees
83
Annual revenue
RMB 100–500M
Website
www.genial.cn
Product categories
Integrated Care, Rehabilitation & HomecareHomecare, long-term care & ageing

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
2001-06-11
Registered capital
CNY 50,000,000
Paid-in capital
CNY 50,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Research and experimental development
Last approval date
2023-07-28
Recognitions
Micro and small enterpriseNational High-Tech Enterprise
Listing
Listed on a regional equity market

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

12021 · K210014
32023 · K231250
22024 · K240333

FDA listed device types

System, Measurement, Blood-Pressure, Non-Invasive 1Clinical Electronic Thermometer 1Continuous Measurement Thermometer 1Oximeter 1Thermometer, Clinical Color Change 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20252090497强脉冲光治疗仪Class II
CN粤械注准20252070430腕式电子血压计Class II
CN粤械注准20252070397臂式电子血压计Class II
CN粤械注准20232081087网式雾化器Class II
EU06936827004522Digital ThermometerClass IIa
EU06936827004867Digital Themmometer (T1 series)Class IIa
EU06936827002139Digital Themmometer (T2 series)Class IIa
EU06936827002122Digital Themmometer (T2 series)Class IIa
UK45617Digital Blood Pressure Monitor (Arm Type) with/without Bluetooth AppClass IIa
UK45617Digital Blood Pressure Monitor (Wrist Type)Class IIa
UK17887Infrared Ear thermometerClass IIa
USK240333Wearable Digital Thermometer (T31)2024-10-30
USK232678Digital Thermometer, Model T28, T28L2024-01-31
USK231250Digital Blood Pressure Monitor2023-11-28
BR10343209043TERMÔMETRO CLÍNICO DIGITALClass II
BR83060769003Termômetro Digital PulseClass II
BR83060769001Oxímetro PulseClass II

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