HomeChinaGuangzhou Potent Medical Equipment Jointstock Co.. Ltd.

Guangzhou Potent Medical Equipment Jointstock Co.. Ltd.

China · Guangzhou · www.potent-medical.com
✓ Record-verifiedregistrations found in 6 marketsUnified social credit code 91440116766133499N

This company holds 9 NMPA certificates in China and has registrations in United States, Brazil, Saudi Arabia, Hong Kong, Israel — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
9China registrations
Class II 4Class III 5
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
4listed device types
Class I 0Class II 4Class III 0
plus 9 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
2 including historic records
SASaudi ArabiaSFDA
1registered 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
2valid listings
Class III 2
ILIsraelAMAR
1registrations
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.

United States9 registration records, 7 510(k), 0 PMA, 1 excluded
China9 certificates (Class III 5 / II 4 / I 0), as of 2026-09-04
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · GUANGZHOU POTENT MEDICAL EQUIPMENT JOINT-STOCK CO., LTD · Guangzhou Potent Medical Equipment Joint-Stock Co.,Ltd.

Regulatory identity

Unified social credit code
91440116766133499N
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Guangzhou
Social-insurance enrolees
97
Annual revenue
RMB 100–500M
Website
www.potent-medical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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
2004-09-12
Registered capital
CNY 13,586,957
Paid-in capital
CNY 13,586,957
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Technology promotion and application services
Last approval date
2026-06-04
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseNational SRDI "Little Giant"SRDI SMEInnovative SMEAbove-designated-size industrial enterprise
Listing
Delisted from the NEEQ

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

52025 · K252771
22026 · K253951

FDA listed device types

Device, Cystometric, Hydraulic 1Lithotriptor, Electro-Hydraulic 1Powered Laser Surgical Instrument 1Uroflowmeter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20233010853钬(Ho:YAG)激光治疗机Class III
CN国械注准20223011238钬激光治疗机Class III
CN国械注准20183011597体内冲击波碎石仪Class III
CN国械注准20183010161半导体激光治疗机Class III
USK253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)2026-03-06
USK253633Holmium Laser Therapeutic Apparatus (HZ-40)2026-01-24
USK252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)2025-11-24
SAME0000013138SFDAA00001Patient Lift System

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