110365
IV
Expired.
Stents, Vascular, Coronary, Balloon-Expandableๆฏๆถ,่ก็ฎกๆฏๆถ,ๅ ็ถๅจ่ๆฏๆถ,็ๅๆฉๅผ ๆฏๆถ
This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Coronary, Balloon-Expandable. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Stents, Vascular, Coronary, Balloon-Expandable
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20422
Product Code Detail
20422 Stents, Vascular, Coronary, Balloon-Expandable
State
Expired.
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
OrbusNeich Medical B.V.
Orbusneich Medical, B.V.
Netherlands
่ทๅ
ฐ
Drs. W. van Royenstraat 5, 3871 AN Hoevelaken, The Netherlands
Drs. W. van Royenstraat 5, 3871 AN Hoevelaken, ่ทๅ
ฐ
Authorised Representative (AR)
OrbusNeich Medical Company Limited
ไธ่ๅป็ๆ้ๅ
ฌๅธ
31097271/31097216
Regulatory Timeline
Registration Date
October 25, 2016
Expiry Date
October 25, 2021
Product Models
Azule CoCr Alloy Coronary Stent Delivery System (225-092-6A, 225-132-6A, 225-152-6A, 225-182-6A, 225-232-6A, 227-092-6A, 227-132-6A, 227-152-6A, 227-182-6A, 227-232-6A, 230-092-6A, 230-132-6A, 230-152-6A, 230-182-6A, 230-232-6A, 230-282-6A, 230-332-6A, 235-092-6A, 235-132-6A, 235-152-6A, 235-182-6A, 235-232-6A, 235-282-6A, 235-332-6A, 240-092-6A, 240-132-6A, 240-152-6A, 240-182-6A, 240-232-6A, 240-282-6A, 240-332-6A)
Azule CoCr ๅ้ๅ ็ถๅจ่ๆฏๆถ่พ้็ณป็ป (225-092-6A, 225-132-6A, 225-152-6A, 225-182-6A, 225-232-6A, 227-092-6A, 227-132-6A, 227-152-6A, 227-182-6A, 227-232-6A, 230-092-6A, 230-132-6A, 230-152-6A, 230-182-6A, 230-232-6A A, 230-282-6A, 230-332-6A, 235-092-6A, 235-132-6A, 235-152-6A, 235-182-6A, 235-232-6A, 235-282-6A, 235-332-6A, 240-092-6A, 240-132-6A, 240-152-6A, 240-182-6A, 240-232-6A, 240-282-6A, 240-332-6A)