210015
II
current
Recorders, Physiologic, Sleep/Awake录音机, 生理, 睡眠/清醒
This profile provides complete Hong Kong MDACS registration information for Recorders, Physiologic, Sleep/Awake. 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: Recorders, Physiologic, Sleep/Awake
產品資訊： 录音机, 生理, 睡眠/清醒
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
20197
Product Code Detail
20197 Recorders, Physiologic, Sleep/Awake
State
current
Status
N/A
Brand
Nox Sleep System
氮氧化物睡眠系统
Manufacturer (製造商)
Nox Medical
Nox Medical
Iceland
冰岛
Katrínartúni 2, Reykjavík, IS-105, Iceland
卡特里纳图尼 2, 雷克雅未克, IS-105, 冰岛
Authorised Representative (AR)
23323366
Regulatory Timeline
Registration Date
March 21, 2024
Expiry Date
February 03, 2026
Product Models
Nox A1 Recorder (561410), Nox A1 Demo Recorder (561419), Nox A1 EEG Head Cable Package - Adult (562110), Nox A1 EEG Head Cable Package - Pediatric (562111), Nox A1 EEG 5 Lead Gold Electrode Cable Package (554411), Nox USB Mini Cable Package (562011), Noxturnal App (536210), Nox Clip Strap Package (569013), Nox Cl Access Point, Nox A1s Recorder (561411)
Nox A1 记录器 (561410)、Nox A1 演示记录器 (561419)、Nox A1 脑电图头电缆包 - 成人 (562110)、Nox A1 脑电图头电缆包 - 儿科 (562111)、Nox A1 脑电图 5 引线金电极电缆包 (554411)、Nox USB 迷你电缆包 (562011)、Noxturnal 应用程序 (536210)、Nox 夹带包 (569013)、Nox Cl 接入点、Nox A1s 记录器 (561411)