Catheters, Vascular, Guiding

导管,血管,引导

Penumbra, Inc.·IV·Hong Kong MDACS·Registered November 27, 2023

Device overview

Risk class: IV
Product code: 17846
State: current
Status: N/A
Brand: Penumbra Access Catheter System
Penumbra 通路导管系统
Product code detail: 17846 Catheters, Vascular, Guiding

Manufacturer (製造商)

Name: Penumbra, Inc.
Penumbra,Inc.
Country: United States
美国
Address: One Penumbra Place, Alameda, CA 94502, USA
半影广场一号,阿拉米达,CA 94502,美国

Authorised representative (AR)

Name: Asia Actual Limited
Phone: 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)

About this record

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