Medical Device Division · registration 220318ActiveMerit Medical Systems
Hong KongDilators, Surgical, VascularClass IIMerit Medical Systems, Inc
Official record identity
- MDACS listing number
- 220318
- Model name
- Merit MAK (Mini Access Kit) (PAKM4NPD4, PAKM4NPD7, PAKM5NPD4, PAKM5NPD7, PAKS4NPD4, PAKS4NPD7, PAKS5NPD4, PAKS5NPD7), PreludeEASE Hydrophilic Sheath Introducer (PAKPHR47NPD4, PAKPHR47NPD7)
- Registration date
- October 14, 2022
- Expiry date
- October 14, 2027
- 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
Dilators, Surgical, Vascular
Additional source fields
- AMD nomenclature code
- 11268
- 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.