220093
IV
current
Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Deliveryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่ใ่ฏ็ฉ่พ้
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery. 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, Drug Delivery
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่ใ่ฏ็ฉ่พ้
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18645
Product Code Detail
18645 Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery
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
March 14, 2022
Expiry Date
March 14, 2027
Product Models
Pantera Lux Paclitaxel Releasing PTCA Balloon Catheter (365110, 365120, 365125, 365130, 365135, 365111, 365121, 365126, 365131, 365136, 365112, 365122, 365127, 365132, 365137, 365113, 365123, 365128, 365133, 365138, 365114, 365124, 365129, 365134, 365139)
Pantera lux็ดซๆ้้ๆพPTCA็ๅๅฏผ็ฎก(365110,365120,365125,365130,365135,365111,365121,365126,365131,365136,365112,365122,365127,365132,365137,365113,365123,365128,365133,365138,365114,365124,365129,365134,365139)