140105
IV
Expired.
Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting่ก็ฎกๆฏๆถใๅ ็ถๅจ่ๆฏๆถใ็ๅๆฉๅผ ๆฏๆถใ่ฏ็ฉๆด่ฑๆฏๆถ
This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting. 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, Drug-Eluting
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20383
Product Code Detail
20383 Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
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
March 01, 2019
Expiry Date
April 07, 2024
Product Models
Combo Bio-Engineered Sirolimus Eluting Stent (225-092-8, 225-132-8, 225-152-8, 225-182-8, 225-232-8, 227-092-8, 227-132-8, 227-152-8, 227-182-8, 227-232-8, 230-092-8, 230-132-8, 230-152-8, 230-182-8, 230-232-8, 230-282-8, 230-332-8, 235-092-8, 235-132-8, 235-152-8, 235-182-8, 235-232-8, 235-282-8, 235-332-8, 240-092-8, 240-132-8, 240-152-8, 240-182-8, 240-232-8, 240-282-8, 240-332-8, 225-282-8, 225-332-8, 227-282-8, 227-332-8, 230-382-8, 235-382-8, 240-382-8)
็ปๅ็็ฉๅทฅ็จ่ฅฟ็ฝ่ซๅธๆด่ฑๆฏๆถ(225-092-8, 225-132-8, 225-152-8, 225-182-8, 225-232-8, 227-092-8, 227-132-8, 227-152-8, 227-182-8, 227-232-8, 230-092-8, 230-132-8, 230-152-8, 230-182-8, 230-232-8, 230-282-8, 230-332-8, 235-092-8, 235 -132-8, 235-152-8, 235-182-8, 235-232-8, 235-282-8, 235-332-8, 240-092-8, 240-132-8, 240-152-8, 240-182-8, 240-232-8, 240-282-8, 240-332-8, 225-282-8, 225-332-8, 227-282-8, 227-332-8, 230-382-8, 235-382-8, 240-382-8)