Pure Global
190382
IV
current

Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting่ก€็ฎกๆ”ฏๆžถใ€ๅ† ็ŠถๅŠจ่„‰ๆ”ฏๆžถใ€็ƒๅ›Šๆ‰ฉๅผ ๆ”ฏๆžถใ€่ฏ็‰ฉๆด—่„ฑๆ”ฏๆžถ

This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting. 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: Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting

็”ขๅ“่ณ‡่จŠ๏ผš ่ก€็ฎกๆ”ฏๆžถใ€ๅ† ็ŠถๅŠจ่„‰ๆ”ฏๆžถใ€็ƒๅ›Šๆ‰ฉๅผ ๆ”ฏๆžถใ€่ฏ็‰ฉๆด—่„ฑๆ”ฏๆžถ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20383
Product Code Detail
20383 Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Elixir Medical Corporation
Elixir Medical Corporation
United States
็พŽๅ›ฝ
920 N. McCarthy Blvd., Suite 100, Milpitas, CA 95035, USA
920 N.้บฆๅก้”กๅคง้“,ๅฅ—ๆˆฟ100,็ฑณๅฐ”็šฎๅก”ๆ–ฏ,CA 95035,็พŽๅ›ฝ
Authorised Representative (AR)
Emergo Hong Kong Limited
ๅŸƒ้ป˜้ซ˜้ฆ™ๆธฏๆœ‰้™ๅ…ฌๅธ
22769196
Regulatory Timeline
Registration Date
September 20, 2024
Expiry Date
December 05, 2029
Product Models
DynamX Novolimus Eluting Coronary Bioadaptor System (VCR2214, VCR2218, VCR2223, VCR2228, VCR2232, VCR2238, VCR2243, VCR2246, VCR2248, VCR2514, VCR2518, VCR2523, VCR2528, VCR2532, VCR2538, VCR2543, VCR2546, VCR2548, VCR2714, VCR2718, VCR2723, VCR2728, VCR2732, VCR2738, VCR2743, VCR2746, VCR2748, VCR3014, VCR3018, VCR3023, VCR3028, VCR3032, VCR3038, VCR3043, VCR3046, VCR3048, VCR3514, VCR3518, VCR3523, VCR3528, VCR3532, VCR3538, VCR3543, VCR3546, VCR3548, VCR4015, VCR4018, VCR4023, VCR4028, VCR4032, VCR4038, VCR4041)
DynamX Novolimus ๆด—่„ฑๅ† ็ŠถๅŠจ่„‰็”Ÿ็‰ฉ้€‚้…ๅ™จ็ณป็ปŸ (VCR2214, VCR2218, VCR2223, VCR2228, VCR2232, VCR2238, VCR2243, VCR2246 VCR2248, VCR2248, VCR2514 VCR2518, VCR2523, VCR2528, VCR2532, VCR2538, VCR2543, VCR2546, VCR2548, VCR2714, VCR2718, VCR2723, VCR2728, VCR2732 VCR2738, , VCR2743, VCR2746, VCR2748, VCR3014, VCR3018, VCR3023, VCR3028, VCR3032, VCR3038, VCR3043, VCR3046, VCR3048, VCR3514, VCR3518, VCR3523, VCR3528, VCR3532, VCR3538, VCR3543, VCR3546, VCR3548, VCR4015, VCR4018, VCR4023, VCR4028, VCR4032ใ€VCR4038 VCR4041)