180507
IV
current
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
current
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
November 27, 2023
Expiry Date
December 06, 2028
Product Models
COMBO Plus Dual Therapy Stent (COMBO Plus Stent) (225-092-11 , 225-132-11 , 225-152-11 , 225-182-11 , 225-232-11 , 225-282-11 , 225-332-11 , 227-092-11 , 227-132-11 , 227-152-11 , 227-182-11 , 227-232-11 , 227-282-11 , 227-332-11 , 230-092-11 , 230-132-11 , 230-152-11 , 230-182-11 , 230-232-11 , 230-282-11 , 230-332-11 , 230-382-11 , 235-092-11 , 235-132-11 , 235-152-11 , 235-182-11 , 235-232-11 , 235-282-11 , 235-332-11 , 235-382-11 , 240-092-11 , 240-132-11 , 240-152-11 , 240-182-11 , 240-232-11 , 240-282-11 , 240-332-11 , 240-382-11)
COMBO ๅ ๅ่ๆฒป็ๆฏๆถ (COMBO ๅ ๆฏๆถ) (225-092-11 , 225-132-11 , 225-152-11 , 225-182-11 , 225-232-11 , 225-282-11 , 225-332-11 , 227-092-11 , 227-132-11 , 227-152-11 , 227-182-11 , 227-232-11 , 227-282-11 , 227-332-11 , 230-092-11 , 230-132-11 , 2300 -152-11 , 230-182-11 , 230-232-11 , 230-282-11 , 230-332-11 , 230-382-11 , 235-092-11 , 235-132-11 , 235-152-11 , 235-182-11 , 235-232-11 , 235-282-11 , 235-332-11 , 235-382-11 , 240-092-11 , 240-132-11 , 240-152-11 , 240-182-11 , 240-232-11 , 240-282-11 , 240-332-11 , 240-382-11)