Pure Global
220002
II
current

Electrocardiographs, Ambulatory, Continuousๅฟƒ็”ตๅ›พไปช,ๅŠจๆ€,่ฟž็ปญ

This profile provides complete Hong Kong MDACS registration information for Electrocardiographs, Ambulatory, Continuous. 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: Electrocardiographs, Ambulatory, Continuous

็”ขๅ“่ณ‡่จŠ๏ผš ๅฟƒ็”ตๅ›พไปช,ๅŠจๆ€,่ฟž็ปญ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
18361
Product Code Detail
18361 Electrocardiographs, Ambulatory, Continuous
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
BTL Industries Limited
Btl Industries Limited
United Kingdom
่‹ฑๅ›ฝ
161 Cleveland Way, Stevenage, Hertfordshire SG1 6BU, United Kingdom
161 Cleveland Way, Stevenage, Hertfordshire SG1 6BU, ่‹ฑๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
January 20, 2022
Expiry Date
January 20, 2027
Product Models
BTL-08 Holter H100, BTL-08 Holter H300, BTL-08 Holter H600
BTL-08 ๅŠจๆ€ๅฟƒ็”ตๅ›พH100, BTL-08 ๅŠจๆ€ๅฟƒ็”ตๅ›พH300, BTL-08 ๅŠจๆ€ๅฟƒ็”ตๅ›พH600