Medical Device Division · registration 240410ActiveEdan Instruments
Hong KongRecorders, Electrocardiograph/Blood Pressure, AmbulatoryClass IIEdan Instruments, Inc.
Official record identity
- MDACS listing number
- 240410
- Model name
- Holter ECG and ABP system (SA-20, SA-19, SA-18, SA-16, SA-15)
- Registration date
- September 24, 2024
- Expiry date
- September 23, 2029
- Source update date
- October 28, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
- Published category
- Recorders, Electrocardiograph/Blood Pressure, Ambulatory
Official value: II
Published parties
- Registrant / registration holder
- Pengbang Medical (HK) Co., Limited
- Manufacturer
- Edan Instruments, Inc.
Additional source fields
- 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.