Medical Device Division · registration 220046Active

Edan Instruments

Name: Edan Instruments — Medical Device Division 220046
Creator: Edan Instruments, Inc.
Keywords: Edan Instruments, Edan Instruments, 220046, Electrocardiographs, Multichannel, Interpretive, Medical Device Division

Hong KongElectrocardiographs, Multichannel, InterpretiveClass IIEdan Instruments, Inc.

Verified

Official record identity

MDACS listing number: 220046
Model name: SE-1202, SE-1202E
Registration date: May 22, 2025
Expiry date: February 08, 2027
Status: Active

Classification

Risk class: Class II
Published category: Electrocardiographs, Multichannel, Interpretive

Published parties

Registrant / registration holder: Pengbang Medical (HK) Co., Limited
Manufacturer: Edan Instruments, Inc.

Official description

Electrocardiographs, Multichannel, Interpretive

Additional source fields

AMD nomenclature code: 16231
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, P.R.C.
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.