241010
IV
current
Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery导管、血管、血管成形术、球囊、外周动脉、药物输送
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
產品資訊： 导管、血管、血管成形术、球囊、外周动脉、药物输送
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 (製造商)
CARDIONOVUM GmbH
Cardionovum Gmbh
Germany
德国
Am Bonner Bogen 2, 53227 Bonn, Germany
Am Bonner Bogen 2, 53227 波恩, 德国
Authorised Representative (AR)
IntegMed Limited
英特曼有限公司
35273026
Regulatory Timeline
Registration Date
August 29, 2024
Expiry Date
August 28, 2029
Product Models
APERTO OTW Paclitaxel Releasing Hemodialysis Shunt Balloon Dilatation Catheter (APS 4.00-20 OTW, APS 4.00-40 OTW, APS 4.00-60 OTW, APS 5.00-20 OTW, APS 5.00-40 OTW, APS 5.00-60 OTW, APS 6.00-20 OTW, APS 6.00-40 OTW, APS 6.00-60 OTW, APS 7.00-20 OTW, APS 7.00-40 OTW, APS 7.00-60 OTW, APS 8.00-20 OTW, APS 8.00-40 OTW, APS 8.00-60 OTW, APL 9.00-20 OTW, APL 9.00-40 OTW, APL 9.00-60 OTW, APL 10.00-20 OTW, APL 10.00-40 OTW, APL 10.00-60 OTW, APL 12.00-20 OTW, APL 12.00-40 OTW)
APERTO OTW 紫杉醇释放血液透析分流球囊扩张导管(APS 4.00-20 OTW、APS 4.00-40 OTW、APS 4.00-60 OTW、APS 5.00-20 OTW、APS 5.00-40 OTW、APS 5.00-60 OTW、APS 6.00-20 OTW、APS 6.00-40 OTW、APS 6.00-60 OTW、APS 7.00-20 OTW、APS 7.00-40 OTW、APS 7.00-60 OTW、APS 8.00-20 OTW、APS 8.00-40 OTW、APS 8.00-60 OTW、APL 9.00-20 OTW、 APL 9.00-40 OTW, APL 9.00-60 OTW, APL 10.00-20 OTW, APL 10.00-40 OTW, APL 10.00-60 OTW, APL 12.00-20 OTW, APL 12.00-40 OTW)