HomeChinaWuhan Pioon Technology Co., Ltd

Wuhan Pioon Technology Co., Ltd

China · Wuhan Hubei · www.pioon.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000018399Unified social credit code 914201003335051389

This company holds 2 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
2China registrations
Class III 2
as of 2026-09-04
EUEuropean UnionEUDAMED
8UDI-DI device records
Class IIb 8
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 3 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class IIb 4
BRBrazilANVISA
0registered devices
1 including historic records
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
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
1valid listings
Class III 1
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.

European Union8 raw hits, 0 excluded, 8 confirmed
United States3 registration records, 7 510(k), 0 PMA
China2 certificates (Class III 2 / II 0 / I 0), as of 2026-09-04
United Kingdom4 confirmed, 0 excluded
Manufacturer names merged into this page: Wuhan Pioon Technology Co.,Ltd. · WUHAN PIOON TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000018399
EU authorised representative
Wellkang Ltd
UK responsible person
MedPath Limited
Unified social credit code
914201003335051389
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Wuhan Hubei
Social-insurance enrolees
90
Annual revenue
RMB 50–100M
Website
www.pioon.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
2015-04-29
Registered capital
CNY 6,666,666
Paid-in capital
CNY 6,666,666
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Computer, communications and other electronic equipment
Last approval date
2024-08-01
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEGazelle 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

22023 · K231548
32024 · K240747
22025 · K243764

FDA listed device types

Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253011190半导体激光治疗仪Class III
CN国械注准20203090475半导体激光治疗仪Class III
EU06974624060051Class IIb
EU06974624060099Class IIb
EU06974624060068Class IIb
EU06974624060037Class IIb
UK60341Medical Diode LaserClass IIb
UK60340Medical Diode LaserClass IIb
UK60341Medical Diode LaserClass IIb
USK243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)2025-05-08
USK250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)2025-04-04
USK240747Medical Diode Laser (M2-GK)2024-06-17

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