Medical Device Division · registration 230111ActiveEdan Instruments
Hong KongScanning Systems, UltrasonicClass IIEdan Instruments, Inc.
Official record identity
- MDACS listing number
- 230111
- Model name
- Diagnostic Ultrasound System (Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX28, Acclarix AX25, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX18, Acclarix AX15)
- Registration date
- March 22, 2023
- Expiry date
- March 22, 2028
- Source update date
- December 20, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Pengbang Medical (HK) Co., Limited
- Manufacturer
- Edan Instruments, Inc.
Official description
Scanning Systems, Ultrasonic
Additional source fields
- AMD nomenclature code
- 14278
- Traditional Chinese local responsible person
- 鵬邦醫療器械（香港）有限公司
- Local responsible person phone
- 66499391
- Published manufacturer address
- #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, 518122 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
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.