Pure Global
130114
III
current

Monitors, Bedside, Electroencephalography็›‘ๆŠคไปช, ๅบŠๆ—, ่„‘็”ตๅ›พ

This profile provides complete Hong Kong MDACS registration information for Monitors, Bedside, Electroencephalography. 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, Electroencephalography, Bedside

็”ขๅ“่ณ‡่จŠ๏ผš ็›‘ๆŠคไปช, ็”Ÿ็†, ่„‘็”ตๅ›พ, ๅบŠ่พน

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
12602
Product Code Detail
12602 Monitors, Physiologic, Electroencephalography, Bedside
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Covidien llc
Covidien Llc
United States
็พŽๅ›ฝ
15 Hampshire Street, Mansfield MA 02048, USA
15 ๆฑ‰ๆ™ฎ้ƒก่ก—, ๆ›ผๆ–ฏ่ฒๅฐ”ๅพท MA 02048, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
June 14, 2023
Expiry Date
May 24, 2028
Product Models
BIS Complete Monitoring System (186-1046), BISx (186-0195-AMS), BISX4 (186-0224-AMS), Flexible Circuit Sensors (186-0106, 186-0200, 186-0212), BIS Patient Interface Cable (186-0107)
BISๅฎŒๆ•ด็›‘ๆŠค็ณป็ปŸ(186-1046),BISx(186-0195-AMS),BISX4(186-0224-AMS),ๆŸ”ๆ€ง็”ต่ทฏไผ ๆ„Ÿๅ™จ(186-0106,186-0200,186-0212),BISๆ‚ฃ่€…ๆŽฅๅฃ็”ต็ผ†(186-0107)