150314
IV
current
Catheters, Vascular, Angioplasty, Balloonๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅ
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon. 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
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17184
Product Code Detail
17184 Catheters, Vascular, Angioplasty, Balloon
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Biotronik AG
Biotronik Ag
Switzerland
็ๅฃซ
Ackerstrasse 6, 8180 Bulach, Switzerland
Ackerstrasse 6, 8180 ๅธๆ่ตซ, ็ๅฃซ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
January 19, 2022
Expiry Date
October 28, 2025
Product Models
Passeo-18 Lux Paclitaxel-releasing PTA Balloon Catheter (370843, 370844, 370845, 370846, 370847, 370848, 370849, 370850, 370851, 370852, 370853, 370854, 370855, 370856, 370857, 370858, 370859, 370860, 370861, 370862, 370863, 370864, 370865, 370866, 370867, 370868, 370869, 370870, 370871, 370872, 379860, 379861, 379862, 379863, 379864, 379865, 379866, 379867, 379868, 379869, 379870, 379871)
Passeo-18 ๅๅ
ๆฏ็ดซๆ้้ๆพPTA็ๅๅฏผ็ฎก (370843, 370844, 370845, 370846, 370847, 370848, 370849, 370850, 370851, 370852, 370853, 370854, 370855, 370856, 370857, 370858, 370859, 370860, 370861, 370862, 370863, 370864, 370865, 370866, 370867, 370868, 370869, 370870, 370871, 370872, 379860, 379861, 379862, 379863, 379864, 379865, 379866, 379867, 379868, 379869, 379870, 379871)