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Medical Device Division · registration 200191Active

PIOLAX MEDICAL DEVICES

Hong KongCatheters, Vascular, AngiographyClass IIPIOLAX MEDICAL DEVICES, INC.
Official record identity
MDACS listing number
200191
Model name
Micro Catheter BISHOP (MC16-S110BY, MC16-S130BY, MC16-A130BY, MC16-D130BY, MC16-S150BY), BISHOP HF (MC21-S110B, MC21-S130B, MC21-S150B)
Registration date
April 14, 2025
Expiry date
June 22, 2030
Status
Active
Official value: Valid
Classification
Risk class
Class II
Official value: II
Published category
Catheters, Vascular, Angiography
Published parties
Registrant / registration holder
Synapse Therapeutics Limited
Official description

Catheters, Vascular, Angiography

Additional source fields
AMD nomenclature code
10688
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
b
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.