Medical Device Division · registration 210307ActiveEdan Instruments
Hong KongMonitors, Physiologic, Fetal, Intrapartum, BedsideClass IIIEdan Instruments Inc.
Official record identity
- MDACS listing number
- 210307
- Model name
- F15, F15 Air
- Registration date
- May 28, 2026
- Expiry date
- September 02, 2031
- Source update date
- June 03, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Pengbang Medical (HK) Co., Limited
- Manufacturer
- Edan Instruments Inc.
Official description
Monitors, Physiologic, Fetal, Intrapartum, Bedside
Additional source fields
- AMD nomenclature code
- 18340
- 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
- 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.