Medical Device Division · registration 210442ActiveMerit Medical Systems
Hong KongCatheter Introducers, VascularClass IVMerit Medical Systems, Inc
Official record identity
- MDACS listing number
- 210442
- Model name
- Prelude Prestige Splittable Sheath Introducer (PLP-1005, PLP-1006, PLP-1007, PLP-1008, PLP-1008.5, PLP-1009, PLP-1009.5, PLP-1010, PLP-1010.5, PLP-1011, PLP-1012, PLP-1012.5, PLP-1013, PLP-1014, PLP-1015, PLP-1016, PLP-2505, PLP-2506, PLP-2507, PLP-2508, PLP-2509, PLP-2510, PLP-2511, PLP-2512, PLP-2513, PLP-2514, PLP-2515, PLP-2516)
- Registration date
- January 17, 2022
- Expiry date
- January 17, 2027
- Source update date
- January 21, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Merit Medical Asia Company Limited
- Manufacturer
- Merit Medical Systems, Inc
Official description
Catheter Introducers, Vascular
Additional source fields
- AMD nomenclature code
- 34022
- Local responsible person phone
- 22076851
- Published manufacturer address
- 1600 West Merit Parkway, South Jordan, Utah, 84095, USA
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.