Medical Device Division · registration 190334ActiveMerit Medical Systems
Hong KongCatheters, Bronchial, BalloonClass IIMerit Medical Systems, Inc
Official record identity
- MDACS listing number
- 190334
- Model name
- ELATION BALLOON DILATOR Pulmonary Balloon Dilation Catheter (P6L20, P8L20, P10L20, P12L20, P6L30, P8L30, P10L30, P12L30, P12L55, P15L55, P18L55)
- Registration date
- June 24, 2024
- Expiry date
- October 14, 2029
- 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
Catheters, Bronchial, Balloon
Additional source fields
- AMD nomenclature code
- 17827
- 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.