230442
IV
current
Catheters, Vascular, Guiding导管,血管,引导
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Guiding. 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, Guiding
產品資訊： 导管,血管,引导
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17846
Product Code Detail
17846 Catheters, Vascular, Guiding
State
current
Status
N/A
Brand
Penumbra Access Catheter System
Penumbra 通路导管系统
Manufacturer (製造商)
Penumbra, Inc.
Penumbra,Inc.
United States
美国
One Penumbra Place, Alameda, CA 94502, USA
半影广场一号,阿拉米达,CA 94502,美国
Authorised Representative (AR)
2893 3118
Regulatory Timeline
Registration Date
November 27, 2023
Expiry Date
November 27, 2028
Product Models
NEURON Intracranial Access System (PND6F070956, PND6F0701058, PND6F070956M, PND6F0701058M, PND6F11512, PND6F11512M, PND6F1156, PND6F1156M, PND6F10512, PND6F10512M, PND6F1056, PND6F1056M), NEURON MAX System (PNML6F088804M, PNML6F088904M, PNML6F088704M, PNML6F088704, PNML6F088804, PNML6F088904, PNML6F0881004M, PNML6F0881004, PNML6F088704MR, PNML6F088704R, PNML6F088804MR, PNML6F088804R, PNML6F088904MR, PNML6F088904R, PNML6F0881004MR, PNML6F0881004R, PNS6F125SIM, PNS6F125H1, PNS6F125BER, PNS6F125SIMV, PNS6F105SIM, PNS6F105H1, PNS6F105BER, PNS6F105SIMV), Benchmark Intracranial Access System (BMK6F95M, BMK6F105M, BMK6F115M), Benchmark BMX96 System (BMX9680, BMX9690, BMX96100, BMX9680BER105, BMX9690BER125, BMX9690SIM125, BMX9690SIMV125, BMX96100BER125, BMX96100H1125, BMX96100SIM125, BMX96100SIMV125)
NEURON 颅内通路系统(PND6F070956、PND6F0701058、PND6F070956M、PND6F0701058M、PND6F11512、PND6F11512M、PND6F1156、PND6F1156M、PND6F10512、PND6F10512M、PND6F1056、PND6F1056M)、NEURON MAX 系统(PNML6F088804M、PNML6F088904M、PNML6F088704M、PNML6F088704、PNML6F088804、PNML6F088904、PNML6F0881004M、PNML6F0881004、PNML6F088704MR、PNML6F088704R、PNML6F088804MR、PNML6F088804R、PNML6F088904MR、PNML6F088904R、PNML6F0881004MR、PNML6F0881004R、PNS6F125SIM、PNS6F125H1、PNS6F125BER、 PNS6F125SIMV、PNS6F105SIM、PNS6F105H1、PNS6F105BER、PNS6F105SIMV)、基准颅内通路系统(BMK6F95M、BMK6F105M、BMK6F115M)、基准 BMX96 系统(BMX9680、BMX9690、BMX96100、BMX9680BER105、BMX9690BER125、BMX9690SIM125、BMX9690SIMV125、BMX96100BER125、BMX96100H1125、BMX96100SIM125、BMX96100SIMV125)