Pure Global AI
Medical Device Division · registration 170321Active

Kaneka

Hong KongCatheters, Vascular, Angioplasty, BalloonClass IVKANEKA Corporation
Official record identity
MDACS listing number
170321
Model name
IKAZUCHI Zero (ZE-6-100F, ZE-6-100P, ZE-6-120, ZE-6-150, ZE-6-175, ZE-6-200, ZE-6-225, ZE-6-250, ZE-6-275, ZE-6-300, ZE-6-325, ZE-6-350, ZE-6-375, ZE-6-400, ZE-8-100F, ZE-8-100P, ZE-8-120, ZE-8-150, ZE-8-175, ZE-8-200, ZE-8-225, ZE-8-250, ZE-8-275, ZE-8-300, ZE-8-325, ZE-8-350, ZE-8-375, ZE-8-400, ZE-10-150, ZE-10-175, ZE-10-200, ZE-10-225, ZE-10-250, ZE-10-275, ZE-10-300, ZE-10-325, ZE-10-350, ZE-10-375, ZE-10-400, ZE-12-150, ZE-12-175, ZE-12-200, ZE-12-225, ZE-12-250, ZE-12-275, ZE-12-300, ZE-12-325, ZE-12-350, ZE-12-375, ZE-12-400, ZE-15-150, ZE-15-175, ZE-15-200, ZE-15-225, ZE-15-250, ZE-15-275, ZE-15-300, ZE-15-325, ZE-15-350, ZE-15-375, ZE-15-400, ZE-18-150, ZE-18-175, ZE-18-200, ZE-18-225, ZE-18-250, ZE-18-275, ZE-18-300, ZE-18-325, ZE-18-350, ZE-18-375, ZE-18-400, ZE-20-150, ZE-20-175, ZE-20-200, ZE-20-225, ZE-20-250, ZE-20-275, ZE-20-300, ZE-20-325, ZE-20-350, ZE-20-375, ZE-20-400, ZE-30-150, ZE-30-175, ZE-30-200, ZE-30-225, ZE-30-250, ZE-30-275, ZE-30-300, ZE-30-325, ZE-30-350, ZE-30-375, ZE-30-400 )
Registration date
December 01, 2022
Expiry date
January 12, 2028
Source update date
July 09, 2025
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Catheters, Vascular, Angioplasty, Balloon
Published parties
Registrant / registration holder
Pacific Medical (Hong Kong) Company Limited
Official description

Catheters, Vascular, Angioplasty, Balloon

Additional source fields
AMD nomenclature code
17184
Local responsible person phone
23438009
Published manufacturer address
3-18, 2-Chome, Nakanoshima, Kita-ku, Osaka-city, OSAKA, 530-8288 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.