Medical Device Division · registration 200052Activeev3
Hong KongGuide WiresClass IVev3, Inc.
Official record identity
- MDACS listing number
- 200052
- Model name
- Nitrex Guidewire (N140801, N141802, N143001, N180601, N180603, N180801, N180802, N181804, N181805, N181806, N183001, N183002, N251801, N251802, N252601, N351451, N351452, N351803, N352601, N354001, N350801, N351453, N351455, N351454, N351804, N351805, N352602, N352603, N352604, N353001, N354002)
- Registration date
- December 11, 2024
- Expiry date
- April 14, 2030
- Source update date
- January 08, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Medtronic Hong Kong Medical Limited
- Manufacturer
- ev3, Inc.
Official description
Guide Wires
Additional source fields
- AMD nomenclature code
- 11925
- Traditional Chinese local responsible person
- 美敦力香港醫療有限公司
- Local responsible person phone
- 29191300
- Published manufacturer address
- 4600 Nathan Lane North, Plymouth, Minnesota, 55442, USA
- 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.