190216
II
current
Humidifiers, Artificial Airway, Heat/Moisture Exchange加湿器、人工气道、热/湿交换
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
產品資訊： 加湿器、人工气道、热/湿交换
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 (製造商)
Flexicare Medical Limited
Flexicare Medical Ltd
United Kingdom
英国
Cynon Valley Business Park, Mountain Ash, CF45 4ER, UK
西农谷商业园,山灰,CF45 4ER,英国
Authorised Representative (AR)
Medisource Supply (Asia) Company Limited
普康(亚洲)医疗仪器有限公司
21454442
Regulatory Timeline
Registration Date
April 03, 2024
Expiry Date
July 15, 2029
Product Models
HME-Booster T-Piece with Hygrovent S Bacterial Viral HMEF Small (354-200-000), HME-Booster T-Piece Kit 1 (354-215-010), HME-Booster T-Piece Kit 2 (354-205-010), HME-Booster T-Piece Kit 3 (352-215-010C), HME-Booster T-Piece Kit 4 (354-231-020), HME-Booster T-Piece Kit 5 (354-221-000)
HME 助推器 T 型件,带 Hygrovent S 细菌病毒 HMEF 小型 (354-200-000)、HME 助推器 T 型件套件 1 (354-215-010)、HME 助推器 T 型件套件 2 (354-205-010)、HME 助推器 T 型件套件 3 (352-215-010C)、HME 助推器 T 型件套件 4 (354-231-020)、HME 助推器 T 型件套件 5 (354-221-000)