Medical Device Division · registration 220330ActiveElixir Medical
Hong KongStents, Vascular, Peripheral, Balloon-ExpandableClass IVElixir Medical Corporation
Official record identity
- MDACS listing number
- 220330
- Model name
- DynamX Sprint Sirolimus Eluting BTK Bioadaptor System (VLR2014, VLR2214, VLR2514, VLR2714, VLR2018, VLR2218, VLR2518, VLR2718, VLR2023, VLR2223, VLR2523, VLR2723, VLR2028, VLR2228, VLR2528, VLR2728, VLR2032, VLR2232, VLR2532, VLR2732, VLR2038, VLR2238, VLR2538, VLR2738, VLR2043, VLR2243, VLR2543, VLR2743, VLR2046, VLR2246, VLR2546, VLR2746, VLR2048, VLR2248, VLR2548, VLR2748, VLR3014, VLR3514, VLR4015, VLR3018, VLR3518, VLR4018, VLR3023, VLR3523, VLR4023, VLR3028, VLR3528, VLR4028, VLR3032, VLR3532, VLR4032, VLR3038, VLR3538, VLR4038, VLR3043, VLR3543, VLR4041, VLR3046, VLR3546, VLR3048, VLR3548)
- Registration date
- June 05, 2025
- Expiry date
- October 18, 2027
- Source update date
- July 15, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Asia Actual Limited
- Manufacturer
- Elixir Medical Corporation
Official description
Stents, Vascular, Peripheral, Balloon-Expandable
Additional source fields
- AMD nomenclature code
- 20429
- Local responsible person phone
- 28933118
- Published manufacturer address
- 920 N McCarthy Blvd., Suite 100, Milpitas, CA 95035, USA
- Revision number
- a
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.