180439
IV
current
Catheters, Vascular, Angioplasty, Balloon, Coronaryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary. 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: Catheters, Vascular, Angioplasty, Balloon, Coronary
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
34313
Product Code Detail
34313 Catheters, Vascular, Angioplasty, Balloon, Coronary
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
August 29, 2023
Expiry Date
November 09, 2028
Product Models
Scoreflex NC Coronary Dilatation Catheter (617-104-1 , 617-154-1 , 617-204-1 , 620-104-1 , 620-154-1 , 620-204-1 , 622-104-1 , 622-154-1 , 622-204-1 , 625-104-1 , 625-154-1 , 625-204-1 , 627-104-1 , 627-154-1 , 627-204-1 , 630-104-1 , 630-154-1 , 630-204-1 , 635-104-1 , 635-154-1 , 635-204-1 , 640-104-1 , 640-154-1 , 640-204-1)
Scoreflex NC ๅ ็ถๅจ่ๆฉๅผ ๅฏผ็ฎก (617-104-1 , 617-154-1 , 617-204-1 , 620-104-1 , 620-154-1 , 620-204-1 , 622-104-1 , 622-154-1 , 622-204-1 , 625-104-1 , 625-154-1 , 625 -204-1 , 627-104-1 , 627-154-1 , 627-204-1 , 630-104-1 , 630-154-1 , 630-204-1 , 635-104-1 , 635-154-1 , 635-204-1 , 640-104-1 , 640-154-1 , 640-204-1)