230074
III
current
Radiofrequency Therapy Systems, Tissue Ablation, Cardiacๅฐ้ขๆฒป็็ณป็ปใ็ป็ปๆถ่ใๅฟ่
This profile provides complete Hong Kong MDACS registration information for Radiofrequency Therapy Systems, Tissue Ablation, Cardiac. 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: Radiofrequency Therapy Systems, Tissue Ablation, Cardiac
็ขๅ่ณ่จ๏ผ ๅฐ้ขๆฒป็็ณป็ปใ็ป็ปๆถ่ใๅฟ่
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
18608
Product Code Detail
18608 Radiofrequency Therapy Systems, Tissue Ablation, Cardiac
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BIOTRONIK SE & Co. KG
Biotronik Ag
Germany
ๅพทๅฝ
Woermannkehre 1, 12359 Berlin, Germany
Woermannkehre 1, 12359 ๆๆ, ๅพทๅฝ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
April 26, 2023
Expiry Date
March 02, 2028
Product Models
Qubic RF - RF Ablation Generator (396166), Qubic RF - Control Unit (397627), Qubic RF - Foot Switch (404964), Potential Equalization Cable - SK-5/3m (404965), Connecter Cable - VK-118/0,5m (399466), Connecter Cable - VK-118/5,0m (399467), Connecter Cable - VK-118/30,0m (399468), Connecter Cable - VK-119/3,0m (404966), Connecter Cable - VK-120/1,8m (404967), Connecter Cable - VK-127 Adapter Set (444536), Mains Cable (UK) - NK-16 (330676), Electrosurgical Pads and Cables - PK-153 (404215)
Qubic RF - ๅฐ้ขๆถ่ๅ็ๅจ (396166), Qubic ๅฐ้ข - ๆงๅถๅๅ
(397627), Qubic RF - ่่ธๅผๅ
ณ (404964), ็ตไฝๅ่กก็ต็ผ - SK-5/3m (404965), ่ฟๆฅ็ต็ผ - VK-118/0.5m (399466), ่ฟๆฅ็ต็ผ - VK-118/5.0m (399467), ่ฟๆฅ็ต็ผ - VK-118/30.0m (399468), ่ฟๆฅ็ต็ผ - VK-119/3.0M (404966), ่ฟๆฅ็ต็ผ - VK-120/1.8M (404967), ่ฟๆฅ็ต็ผ - VK-127 ้้
ๅจๅฅไปถ (444536), ๆ็ต็ผ (่ฑๅฝ) - NK-16 (330676), ็ตๅค็งๅซๅ็ต็ผ - PK-153 (404215)