Pure Global
240019
IV
current

Catheters, Cardiac, Electrophysiology, Ablation, Cryotherapyๅฏผ็ฎกใ€ๅฟƒ่„ใ€็”ต็”Ÿ็†ใ€ๆถˆ่žใ€ๅ†ทๅ†ปๆฒป็–—

This profile provides complete Hong Kong MDACS registration information for Catheters, Cardiac, Electrophysiology, Ablation, Cryotherapy. 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: Catheters, Cardiac, Electrophysiology, Ablation, Cryotherapy

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกใ€ๅฟƒ่„ใ€็”ต็”Ÿ็†ใ€ๆถˆ่žใ€ๅ†ทๅ†ปๆฒป็–—

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
27644
Product Code Detail
27644 Catheters, Cardiac, Electrophysiology, Ablation, Cryotherapy
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Medtronic, Inc.
Medtronic Plc
United States
็พŽๅ›ฝ
710 Medtronic Parkway, Minneapolis, Minnesota, USA
710 Medtronic Parkway, ๆ˜Žๅฐผ้˜ฟๆณขๅˆฉๆ–ฏ, ๆ˜Žๅฐผ่‹่พพๅทž, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
January 31, 2024
Expiry Date
January 31, 2029
Product Models
Freezor Cardiac CryoAblation Catheters (207F1, 207F3, 207F5), Freezor MAX Cardiac CryoAblation Catheters (209F3, 209F5), Freezor Xtra Cardiac CryoAblation Catheters (217F1, 217F3, 217F5)
Freezor ๅฟƒ่„ๅ†ทๅ†ปๆถˆ่žๅฏผ็ฎก (207F1, 207F3, 207F5), Freezor MAX ๅฟƒ่„ๅ†ทๅ†ปๆถˆ่žๅฏผ็ฎก (209F3, 209F5), Freezor Xtra ๅฟƒ่„ๅ†ทๅ†ปๆถˆ่žๅฏผ็ฎก (217F1, 217F3, 217F5)