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Authorised representative profile

Biotronik Hong Kong Limited

百多力香港有限公司
Hong Kong MDACS130 represented devices18 applicantsJun 01, 2012 – Oct 15, 2024
VerifiedMDD (Medical Device Division) · MDACS registry
130
Total devices
18
Applicants
2012
First representation
2024
Most recent
AR overview
Authorised representative (EN)
Biotronik Hong Kong Limited
Authorised representative (ZH)
百多力香港有限公司
Phone
31904500
Timeline
First representation
Jun 01, 2012
Most recent
Oct 15, 2024
Regulatory footprint
Search Biotronik Hong Kong Limited across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Risk class distribution
II6
III12
IV112
Applicant partnerships
Top manufacturers represented by this AR
BIOTRONIK SE & Co. KG
45 devices
Biotronik SE & Co. KG
34 devices
Biotronik AG
25 devices
Acutus Medical Inc.
7 devices
IMDS Operations B.V.
4 devices
VascoMed GmbH
3 devices
Biotronik SE & Co.KG
1 devices
ARTHESYS
1 devices
Brivant Ltd.
1 devices
Arthesys
1 devices
Recent registrations
Latest 15 MDACS listings represented by Biotronik Hong Kong Limited
Leads, Implantable Cardiac Pacemaker, Endocardial
导联线、植入式心脏起搏器、心内膜
Oct 15, 2024
Risk class
IV
Applicant
BIOTRONIK SE & Co. KGBiotronik Ag
Monitors, Physiologic, Electrocardiography, Telemetric
监护仪、生理、心电图、遥测
Sep 20, 2024
Risk class
IV
Applicant
BIOTRONIK SE & Co. KGBiotronik Ag
Pacemakers, Cardiac, Implantable
心脏起搏器,心脏,植入式
Aug 29, 2024
Risk class
IV
Applicant
BIOTRONIK SE & Co. KGBiotronik Ag
Catheters, Vascular, Guiding
导管,血管,引导
Aug 16, 2024
Risk class
IV
Applicant
IMDS Operations B.V.IMDS Operations B.V.
Catheters, Vascular, Angioplasty, Balloon, Coronary
导管、血管、血管成形术、球囊、冠状动脉
Aug 16, 2024
Risk class
IV
Applicant
IMDS Operations B.V.IMDS Operations B.V.
Catheters, Vascular, Guiding
导管,血管,引导
Aug 16, 2024
Risk class
IV
Applicant
IMDS Operations B.V.IMDS Operations B.V.
Catheters, Vascular, Guiding
导管,血管,引导
Aug 16, 2024
Risk class
IV
Applicant
IMDS Operations B.V.IMDS Operations B.V.
Stent/Grafts, Vascular, Coronary
支架/移植物,血管,冠状动脉
Apr 18, 2024
Risk class
IV
Applicant
Biotronik AGBiotronik Ag
Leads, Implantable Defibrillator/Cardiac Pacemaker
导线,植入式除颤器/心脏起搏器
Apr 18, 2024
Risk class
IV
Applicant
BIOTRONIK SE & Co. KGBiotronik Ag
Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
导管、血管、血管成形术、球囊、外周动脉
Apr 03, 2024
Risk class
II
Applicant
Biotronik AGBiotronik Ag
Leads, Implantable Cardiac Pacemaker, Endocardial
导联线、植入式心脏起搏器、心内膜
Dec 08, 2023
Risk class
IV
Applicant
BIOTRONIK SE & Co. KGBiotronik Ag
Leads, Implantable Defibrillator/Cardiac Pacemaker
导线,植入式除颤器/心脏起搏器
Dec 08, 2023
Risk class
IV
Applicant
BIOTRONIK SE & Co. KGBiotronik Ag
Programmer/Testers, Implantable Cardiac Pacemaker
编程器/测试仪,植入式心脏起搏器
Oct 09, 2023
Risk class
IV
Applicant
BIOTRONIK SE & Co. KGBiotronik Ag
Stent/Grafts, Vascular, Peripheral
支架/移植物,血管,外周
Oct 05, 2023
Risk class
III
Applicant
Biotronik AGBiotronik Ag
Defibrillator/Pacemakers, Implantable
除颤器/起搏器,植入式
Sep 14, 2023
Risk class
IV
Applicant
BIOTRONIK SE & Co. KGBiotronik Ag
View all 130 devices →
About this profile

Biotronik Hong Kong Limited serves as the authorised representative for 130 medical devices in Hong Kong's MDACS framework. Analyse applicant partnerships, risk class exposure, and recent regulatory activity to understand their market footprint.