190387
IV
current
Monitors, Physiologic, Electrocardiography, Telemetric็ๆคไปชใ็็ใๅฟ็ตๅพใ้ฅๆต
This profile provides complete Hong Kong MDACS registration information for Monitors, Physiologic, Electrocardiography, Telemetric. 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: Monitors, Physiologic, Electrocardiography, Telemetric
็ขๅ่ณ่จ๏ผ ็ๆคไปชใ็็ใๅฟ็ตๅพใ้ฅๆต
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
13988
Product Code Detail
13988 Monitors, Physiologic, Electrocardiography, Telemetric
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BIOTRONIK SE & Co. KG
Biotronik Ag
Woermannkehre 1, 12359 Berlin, GERMANY
Woermannkehre 1, 12359 ๆๆ, ๅพทๅฝ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
September 20, 2024
Expiry Date
December 05, 2029
Product Models
BIOMONITOR III (436066), BIOMONITOR IIIm (450218), Remote Assistant III (435292)
็็ฉ็่งๅจIII(436066),็็ฉ็่งๅจIIIm(450218),่ฟ็จๅฉๆIII(435292)