200487
III
current
Monitors, Physiologic, Blood Gas, Bedside, Transcutaneous็ๆคไปช,็็,่กๆฐ,ๅบๆ,็ป็ฎ
This profile provides complete Hong Kong MDACS registration information for Monitors, Physiologic, Blood Gas, Bedside, Transcutaneous. 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, Blood Gas, Bedside, Transcutaneous
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
17996
Product Code Detail
17996 Monitors, Physiologic, Blood Gas, Bedside, Transcutaneous
State
current
Status
N/A
Brand
SenTec Digital Monitoring System (SDMS)
ๆฃฎๆณฐๅ
ๆฐๅญ็ๆง็ณป็ป
Manufacturer (่ฃฝ้ ๅ)
SenTec AG
SenTec AG
Switzerland
็ๅฃซ
Ringstr. 39, 4106 Therwil, Switzerland
ๆๆฏ็น.39, 4106 ็็ปดๅฐ, ็ๅฃซ
Authorised Representative (AR)
Celki International Limited (Branch: Celki Medical Co.)
ๅฐๅฅๅฝ้
ๆ้ๅ
ฌๅธ
23323366
Regulatory Timeline
Registration Date
August 18, 2022
Expiry Date
December 08, 2025
Product Models
SenTec Digital Monitor (SDM), Sensors (VS-A/P/N, OV-A/P/N), Software (V-STATS_CD), Digital Sensor Adapter Cable (AC-150, AC-250, AC-750), Ear Clip (EC-MI ), Multi-site Attachment Ring for mature/intact skin (MAR-MI, MARe-MI), Multi-site Attachment Ring for sensitive/fragile skin (MAR-SF, MARe-SF), Staysite Adhesive for Multi-Site Attachment Rings (SA-MAR), Membrane Changer, reloadable (MC-R), Membrane Changer, single-use (MC), Membrane Changer Insert (MC-I), Service Gas (GAS-0812), Contact Gel (GEL-04), Single Dose Contact Gel (GEL-SD), PSG Adapter Cable (PSG Cable A, PSG Cable B, PSG Cable C, PSG Cable D, PSG Cable E, PSG Cable F, PSG Cable G, PSG Cable H, PSG Cable J, PSG Cable K, PSG Cable L, PSG Cable N, PSG Cable P, PSG Cable Q, PSG Cable X), Isolation Transformer (RFT100VA-V2)
SenTecๆฐๅญ็่งๅจ(SDM),ไผ ๆๅจ(VS-A / P / N,OV-A/P / N),่ฝฏไปถ(V-STATS_CD),ๆฐๅญไผ ๆๅจ้้
ๅจ็ต็ผ(AC-150,AC-250,AC-750),่ณๅคน(EC-MI),ๆ็/ๅฎๆด็ฎ่ค็ๅค็ซ็น่ฟๆฅ็ฏ(MAR-MI,MARe-MI),ๆๆ/่ๅผฑ็ฎ่ค็ๅค็ซ็น่ฟๆฅ็ฏ(MAR-SF,MARe-SF),ๅค็ซ็น้็็ฏ็ๅ็็ฒๅๅ(SA-MAR),่ๆดๆขๅจ,ๅฏ้ๆฐๅ ่ฝฝ(MC-R),่ๆดๆขๅจ,ไธๆฌกๆงไฝฟ็จ(MC), ่ๆดๆขๅจๆไปถ (MC-I), ๆๅกๆฐไฝ (GAS-0812), ๆฅ่งฆๅ่ถ (GEL-04), ๅๅ้ๆฅ่งฆๅ่ถ (GEL-SD), PSG ้้
ๅจ็ต็ผ(PSG ็ต็ผ AใPSG ็ต็ผ BใPSG ็ต็ผ CใPSG ็ต็ผ DใPSG ็ต็ผ EใPSG ็ต็ผ FใPSG ็ต็ผ GใPSG ็ต็ผ HใPSG ็ต็ผ JใPSG ็ต็ผ KใPSG ็ต็ผ LใPSG ็ต็ผ NใPSG ็ต็ผ Pใ PSG ็ต็ผ QใPSG ็ต็ผ X)ใ้็ฆปๅๅๅจ (RFT100VA-V2)