210235
III
current
Radiofrequency Therapy Systems, Tissue Ablationๅฐ้ขๆฒป็็ณป็ป,็ป็ปๆถ่
This profile provides complete Hong Kong MDACS registration information for Radiofrequency Therapy Systems, Tissue Ablation. 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
็ขๅ่ณ่จ๏ผ ๅฐ้ขๆฒป็็ณป็ป,็ป็ปๆถ่
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
12327
Product Code Detail
12327 Radiofrequency Therapy Systems, Tissue Ablation
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Stryker Instruments, a Division of Stryker Corporation
Stryker Instruments, A Division Of Stryker Corporation
United States
็พๅฝ
4100 East Milham Avenue, Kalamazoo MI 49001-6797, USA
4100ไธ็ฑณๅๅงๅคง้,ๅกๆ้ฉฌ็ฅMI 49001-6797,็พๅฝ
Authorised Representative (AR)
Stryker China Limited
็พๅฝๅฒ่ตๅ
(ไธญๅฝ)ๆ้ๅ
ฌๅธ
39691200
Regulatory Timeline
Registration Date
July 22, 2021
Expiry Date
July 22, 2026
Product Models
MultiGen 2 RF Generator (8400-000-000), 50MM Monopolar Nitinol Electrode (0406-815-005), 100MM Monopolar Nitinol Electrode (0406-815-010), 150MM Monopolar Nitinol Electrode (0406-815-015), 200MM Monopolar Nitinol Electrode (0406-815-020), Venom 100MM Nitinol Electrode (0406-825-010), Venom 150MM Nitinol Electrode (0406-825-015), 50MM MultiGen 2 Electrode (8400-815-005), 100MM MultiGen 2 Electrode (8400-815-010), 150MM MultiGen 2 Electrode (8400-815-015), 200MM MultiGen 2 Electrode (8400-815-020), Venom 100MM MultiGen 2 Electrode (8400-825-010), Venom 150MM MultiGen 2 Electrode (8400-825-015), MultiGen Cable (0406-900-100), Monopolar Return Electrode Cable (0406-850-200)
MultiGen 2 ๅฐ้ขๅ็ๅจ (8400-000-000), 50MM ๅๆ้้่ฏบ็ตๆ (0406-815-005), 100MM ๅๆ้้่ฏบ็ตๆ (0406-815-010), 150MM ๅๆ้้่ฏบ็ตๆ (0406-815-015), 200MM ๅๆ้้่ฏบ็ตๆ (0406-815-020), ๆฏๆถฒ 100MM ้้่ฏบ็ตๆ (0406-825-010), ๆฏๆถฒ 150MM ้้่ฏบ็ตๆ (0406-825-015), 50MM ๅคไปฃ 2 ็ตๆ (8400-815-005), 100MM ๅคไปฃ 2 ็ตๆ (8400-815-010), 150MM ๅคไปฃ 2 ็ตๆ (8400-815-015), 200MM ๅคไปฃ 2 ็ตๆ(8400-815-020), ๆฏๆถฒ 100MM ๅคไปฃ 2 ็ตๆ (8400-825-010), ๆฏๆถฒ 150MM ๅคไปฃ 2 ็ตๆ (8400-825-015), ๅคไปฃ็ต็ผ (0406-900-100), ๅๆ่ฟๅ็ตๆ็ต็ผ (0406-850-200)