Medical Device Division · registration 180296ActiveMerit Medical Systems
Hong KongCatheter Introducers, VascularClass IIMerit Medical Systems, Inc.
Official record identity
- MDACS listing number
- 180296
- Model name
- Prelude Short Sheath Introducer (PSS-5F-4MT, PSS-6F-4MT, PSS-7F-4MT, PSS-8F-4MT, PSS-8F-4-038MT, PSS-5F-4-018MT, PSS-5F-4-035MT, PSS-5F-4-038MT, PSS-6F-4-018MT, PSS-6F-4-035MT, PSS-6F-4-038MT, PSS-7F-4-018MT, PSS-7F-4-035MT, PSS-7F-4-038MT, PSS-8F-4-018MT, PSS-8F-4-035MT)
- Registration date
- March 23, 2023
- Expiry date
- August 22, 2028
- Source update date
- January 21, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
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
- 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.