Medical Device Division · registration 200192Active

PIOLAX MEDICAL DEVICES

Name: PIOLAX MEDICAL DEVICES — Medical Device Division 200192
Creator: PIOLAX MEDICAL DEVICES, INC.
Keywords: PIOLAX MEDICAL DEVICES, PIOLAX MEDICAL DEVICES, 200192, Guide Wires, Cardiovascular, Peripheral, Medical Device Division

Hong KongGuide Wires, Cardiovascular, PeripheralClass IIPIOLAX MEDICAL DEVICES, INC.

Verified

Official record identity

MDACS listing number: 200192
Model name: Hydrophilic Guidewire Run & Run (RUN135-16, RUN165-16, RUN165-16A, RUN180-16, RUN180-16A)
Registration date: April 14, 2025
Expiry date: June 22, 2030
Status: Active

Classification

Risk class: Class II
Published category: Guide Wires, Cardiovascular, Peripheral

Published parties

Registrant / registration holder: Synapse Therapeutics Limited
Manufacturer: PIOLAX MEDICAL DEVICES, INC.

Official description

Guide Wires, Cardiovascular, Peripheral

Additional source fields

AMD nomenclature code: 36601
Traditional Chinese local responsible person: 百谷醫療科技有限公司
Local responsible person phone: 31881638
Published manufacturer address: 2265-3 Kamiyabe-cho, Totsuka-ku, Yokohama-shi, Kanagawa, 245-0053 Japan
Revision number: a

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.