241012
IV
current
Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Deliveryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅคๅจๅจ่ใ่ฏ็ฉ่พ้
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, 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, Peripheral Artery, Drug Delivery
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅคๅจๅจ่ใ่ฏ็ฉ่พ้
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
34320
Product Code Detail
34320 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
CARDIONOVUM GmbH
Cardionovum Gmbh
Germany
ๅพทๅฝ
Am Bonner Bogen 2, 53227 Bonn, Germany
Am Bonner Bogen 2, 53227 ๆณขๆฉ, ๅพทๅฝ
Authorised Representative (AR)
IntegMed Limited
่ฑ็นๆผๆ้ๅ
ฌๅธ
35273026
Regulatory Timeline
Registration Date
August 29, 2024
Expiry Date
August 28, 2029
Product Models
LEGFLOW RX Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (L 2.0-20 RX, L 2.0-40 RX, L 2.0-60 RX, L 2.0-80 RX, L 2.0-100 RX, L 2.0-120 RX, L 2.0-150 RX, L 2.0-200 RX, L 2.50-20 RX, L 2.50-40 RX, L 2.50-60 RX, L 2.50-80 RX, L 2.50-100 RX, L 2.50-120 RX, L 2.50-150 RX, L 2.50-200 RX, L 3.0-20 RX, L 3.0-40 RX, L 3.0-60 RX, L 3.0-80 RX, L 3.0-100 RX, L 3.0-120 RX, L 3.0-150 RX, L 3.50-20 RX, L 3.50-40 RX, L 3.50-60 RX, L 3.50-80 RX, L 3.50-100 RX, L 3.50-120 RX, L 3.50-150 RX, L 4.0-20 RX, L 4.0-40 RX, L 4.0-80 RX, L 4.0-120 RX)
LEGFLOW RX ็ดซๆ้ๅคๅจ็ๅๆฉๅผ ๅฏผ็ฎก(L 2.0-20 RXใL 2.0-40 RXใL 2.0-60 RXใL 2.0-80 RXใL 2.0-100 RXใL 2.0-120 RXใL 2.0-150 RXใL 2.0-200 RXใL 2.50-20 RXใL 2.50-40 RXใL 2.50-60 RXใL 2.50-80 RXใL 2.50-100 RXใL 2.50-120 RXใL 2.50-150 RXใL 2.50-200 RXใ L 3.0-20 RX, L 3.0-40 RX, L 3.0-60 RX, L 3.0-80 RX, L 3.0-100 RX, L 3.0-120 RX, L 3.0-150 RX, L 3.50-20 RX, L 3.50-40 RX, L 3.50-60 RX, L 3.50-80 RX, L 3.50-100 RX, L 3.50-120 RX, L 3.50-150 RX, L 4.0-20 RX, L 4.0-40 RX, L 4.0-80 RX, L 4.0-120 RX)