Monitors, Physiologic, Neurology, Intraoperative

监护仪, 生理, 神经内科, 术中

Dr. Langer Medical GmbH·II·Hong Kong MDACS·Registered January 19, 2023

Device overview

Risk class: II
Product code: 34440
State: current
Status: N/A
Product code detail: 34440 Monitors, Physiologic, Neurology, Intraoperative

Manufacturer (製造商)

Name: Dr. Langer Medical GmbH
Dr. Langer Medical GmbH
Country: Germany
德国
Address: Am Bruckwald 26, 79183 Waldkirch, Germany
Am Bruckwald 26, 79183 瓦尔德基希, 德国

Authorised representative (AR)

Name: Pacific Medical (Hong Kong) Company Limited
Phone: 23438009

Regulatory timeline

Registration date: January 19, 2023
Expiry date: January 19, 2028

Product models

Neuromonitor AVALANCHE XT (20-0023), AVALANCHE XT Headbox (21-0022, 21-0023, 21-0025, 21-0026, 21-0027, 21-0028), AVALANCHE XT Software (30-1100, 30-1101, 30-1102, 30-1103, 30-1104, 30-1105), TWISTER MM Modul (20-0007), AEP Modul (20-0003), AVALANCHE XT Anschlusskabel (41-0018, 41-0019, 41-0020, 41-0036), AVALANCHE XT Mute-Sensor (21-0005, 21-0020), EMG signal acquisition cable (41-0010, 41-0068, 41-0069, 41-0070), Adapter (41-0048, 41-0080), Connection cable stimulation probes (41-0002, 41-0027), Disposable Stimulation Probe (40-1003, 40-1004, 40-1006, 40-1007, 40-1008), Saxophone electrode (42-0068), Adhesive tube electrode (42-9600, 42-9601), Stimulation Cable (41-0073, 41-0074, 41-0075, 41-0105)

神经监测器雪崩 XT (20-0023), 雪崩 XT 流浆箱 (21-0022, 21-0023, 21-0025, 21-0026, 21-0027, 21-0028), 雪崩 XT 软件 (30-1100, 30-1101, 30-1102, 30-1103, 30-1104, 30-1105), 费尔托斯特 MM 模块 (20-0007), AEP 模块 (20-0003), 雪崩 XT 安斯卡贝尔 (41-0018, 41-0019, 41-0020, 41-0036), 雪崩 XT 静音传感器 (21-0005, 21-0020), 肌电图信号采集电缆 (41-0010, 41-0068, 41-0069, 41-0070), 适配器 (41-0048, 41-0080), 连接电缆刺激探头 (41-0002, 41-0027), 一次性刺激探头 (40-1003, 40-1004, 40-1006, 40-1007, 40-1008), 萨克斯电极 (42-0068), 粘性管电极 (42-9600, 42-9601), 刺激电缆 (41-0073, 41-0074, 41-0075, 41-0105)

About this record

This profile provides complete Hong Kong MDACS registration information for Monitors, Physiologic, Neurology, Intraoperative. 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: Monitors, Physiologic, Neurology, Intraoperative

產品資訊： 监护仪, 生理, 神经内科, 术中