Medical Device Division · registration 230207ActiveCovidien
Hong KongVentilators, Intensive CareClass IIICovidien LLC
Official record identity
- MDACS listing number
- 230207
- Model name
- Puritan Bennett 980 Universal Ventilator (980A1ENNISB), Puritan Bennett 980 Universal Ventilator DC Compressor Configuration (980A3ENNISB), Capnography Sensor, Reusable (10087409), End Tidal CO2 Monitoring Option (10084332), Proximal Flow Monitoring Option (10084331), Ped/Adult Expiratory Filter, Disposable (10043551), Ped/Adult CO2 Adapter, Disposable (10078387), Proximal Flow Sensors (10047078), Adult Expiratory Filter, Reusable (10063033), Pediatric and Adult CO2 Airway Adapter, Reusable (10083942), Neonatal and Pediatric CO2 Airway Adapter, Reusable (10083943), Neonatal and Pediatric CO2 Adapter, Disposable (10078386), Exhalation Valve Flow Sensor Reprocessing Kit (10086048), Rechargeable Lithium Ion Battery (10086042), Neonatal Expiratory Bracket & Filter (10095100)
- Registration date
- June 26, 2023
- Expiry date
- June 26, 2028
- Source update date
- July 10, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Medtronic Hong Kong Medical Limited
- Manufacturer
- Covidien LLC
Official description
Ventilators, Intensive Care
Additional source fields
- AMD nomenclature code
- 17429
- Traditional Chinese local responsible person
- 美敦力香港醫療有限公司
- Local responsible person phone
- 29191300
- Published manufacturer address
- 15 Hampshire Street Mansfield MA 02048 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.