Medical Device Division · registration 190382ActiveElixir Medical
Hong KongStents, Vascular, Coronary, Balloon-Expandable, Drug-ElutingClass IVElixir Medical Corporation
Official record identity
- MDACS listing number
- 190382
- Model name
- 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)
- Registration date
- June 05, 2025
- Expiry date
- December 05, 2029
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
Official value: IV
Published parties
- Registrant / registration holder
- Asia Actual Limited
- Manufacturer
- Elixir Medical Corporation
Official description
Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
Additional source fields
- AMD nomenclature code
- 20383
- Local responsible person phone
- 28933118
- Published manufacturer address
- 920 N. McCarthy Blvd., Suite 100, Milpitas, CA 95035, USA
- Revision number
- d
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.