Pure Global
160312
IV
current

Monitors, Physiologic, Multipurpose, Telemetricๆ˜พ็คบๅ™จ, ็”Ÿ็†, ๅคš็”จ้€”, ้ฅๆต‹

This profile provides complete Hong Kong MDACS registration information for Monitors, Physiologic, Multipurpose, 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, Multipurpose, Telemetric

็”ขๅ“่ณ‡่จŠ๏ผš ๆ˜พ็คบๅ™จ, ็”Ÿ็†, ๅคš็”จ้€”, ้ฅๆต‹

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
13987
Product Code Detail
13987 Monitors, Physiologic, Multipurpose, Telemetric
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Germany
ๅพทๅ›ฝ
Woermannkehre 1, 12359 Berlin, Germany
Woermannkehre 1, 12359 ๆŸๆž—, ๅพทๅ›ฝ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็™พๅคšๅŠ›้ฆ™ๆธฏๆœ‰้™ๅ…ฌๅธ
31904500
Regulatory Timeline
Registration Date
April 21, 2021
Expiry Date
August 24, 2026
Product Models
CardioMessenger Smart 3G (419318)
CardioMessenger Smart 3G (419318)