241010
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
CARDIONOVUM GmbH·IV·Hong Kong MDACS·Registered August 29, 2024
Device overview
- Risk class
- IV
- Product code
- 34320
- State
- current
- Status
- N/A
- Product code detail
- 34320 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery
Manufacturer (製造商)
- Name
- CARDIONOVUM GmbHCardionovum Gmbh
- Country
- Germany德国
- Address
- Am Bonner Bogen 2, 53227 Bonn, GermanyAm Bonner Bogen 2, 53227 波恩, 德国
Authorised representative (AR)
- Name
- IntegMed Limited英特曼有限公司
- Phone
- 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)
About this record
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