190215
II
current
Humidifiers, Artificial Airway, Heat/Moisture Exchangeๅ ๆนฟๅจใไบบๅทฅๆฐ้ใ็ญ/ๆนฟไบคๆข
This profile provides complete Hong Kong MDACS registration information for Humidifiers, Artificial Airway, Heat/Moisture Exchange. 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: Humidifiers, Artificial Airway, Heat/Moisture Exchange
็ขๅ่ณ่จ๏ผ ๅ ๆนฟๅจใไบบๅทฅๆฐ้ใ็ญ/ๆนฟไบคๆข
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
15645
Product Code Detail
15645 Humidifiers, Artificial Airway, Heat/Moisture Exchange
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Flexicare Medical Limited
Flexicare Medical Ltd
United Kingdom
่ฑๅฝ
Cynon Valley Business Park, Mountain Ash, CF45 4ER, UK
่ฅฟๅ่ฐทๅไธๅญ,ๅฑฑ็ฐ,CF45 4ER,่ฑๅฝ
Authorised Representative (AR)
Medisource Supply (Asia) Company Limited
ๆฎๅบท(ไบๆดฒ)ๅป็ไปชๅจๆ้ๅ
ฌๅธ
21454442
Regulatory Timeline
Registration Date
April 03, 2024
Expiry Date
July 15, 2029
Product Models
Hygrovent Gold Basic (355-000-000), Hygrovent Gold Comfort (355-001-010E), Hygrovent Gold Standard (355-005-010E), Hygrovent Gold Comfort WFL (355-021-010F), Hygrovent Gold Comfort Plus (355-031-010A), Hygrovent Gold Standard Flex (355-105-015F)
ๆตทๆ ผๆ็น้ป้ๅบๆฌ็ (355-000-000), ๆตทๆ ผๆ็น้ป้่้ๅ (355-001-010E), ๆตทๆ ผๆ็น้ป้ๆ ๅ็ (355-005-010E), ๆตทๆ ผๆ็น้ป้่้ๅ WFL (355-021-010F), ๆตทๆ ผๆ็น้ป้่้ๅ็บง็ (355-031-010A), ๆตทๆ ผๆ็น้ป้ๆ ๅๆๆง็ (355-105-015F)