Pure Global
140082
III
current

Physiologic Monitor Modules, Exhaled Carbon Dioxide็”Ÿ็†็›‘ๆต‹ๆจกๅ—,ๅ‘ผๅ‡บ็š„ไบŒๆฐงๅŒ–็ขณ

This profile provides complete Hong Kong MDACS registration information for Physiologic Monitor Modules, Exhaled Carbon Dioxide. 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: Physiologic Monitor Modules, Exhaled Carbon Dioxide

็”ขๅ“่ณ‡่จŠ๏ผš ็”Ÿ็†็›‘ๆต‹ๆจกๅ—,ๅ‘ผๅ‡บ็š„ไบŒๆฐงๅŒ–็ขณ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
20776
Product Code Detail
20776 Physiologic Monitor Modules, Exhaled Carbon Dioxide
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Respironics Novametrix, LLC
Respironics Novametrix, LLC
United States
็พŽๅ›ฝ
3000 Minuteman Road, Andover, Massachusetts, 01810, USA
3000 Minuteman Road, Andover, Massachusetts, 01810, ็พŽๅ›ฝ
Authorised Representative (AR)
28731887 / 28215111/ 26199663
Regulatory Timeline
Registration Date
April 03, 2024
Expiry Date
March 16, 2029
Product Models
Respironics LoFlo Sidestream CO2 Module (1022054), Respironics Alice, LoFlo, C5 Sidestream Module (1097955), Respironics LoFlo Sidestream CO2 Module for Lutech (1050797), Respironics LoFlo Sidestream CO2 Module for GE (1069879)
Respironics LoFlo ไพงๆต CO2 ๆจกๅ— (1022054), Respironics Alice, LoFlo, C5 ไพงๆตๆจกๅ— (1097955), Respironics LoFlo ไพงๆต CO2 ๆจกๅ—็”จไบŽ Lutech (1050797), Respironics LoFlo ไพงๆต CO2 ๆจกๅ—็”จไบŽ GE (1069879)