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Medical Device Division · registration 180064Cancelled

ev3

Hong KongStent/Grafts, VascularClass IVev3, Inc.
Official record identity
MDACS listing number
180064
Model name
Protege RX Self-Expanding Peripheral Stent System (SEPX-8-6-30-135, SEPX-8-6-40-135, SEPX-10-7-30-135, SEPX-10-7-40-135, SEPX-6-20-135, SEPX-6-30-135, SEPX-6-40-135, SEPX-6-60-135, SEPX-7-20-135, SEPX-7-30-135, SEPX-7-40-135, SEPX-7-60-135, SEPX-8-20-135, SEPX-8-30-135, SEPX-8-40-135, SEPX-8-60-135, SEPX-9-20-135, SEPX-9-30-135, SEPX-9-40-135, SEPX-9-60-135, SEPX-10-20-135, SEPX-10-30-135, SEPX-10-40-135, SEPX-10-60-135)
Registration date
January 04, 2023
Source update date
May 15, 2025
Status
Cancelled
Official value: Delisted
Classification
Risk class
Class IV
Official value: IV
Published category
Stent/Grafts, Vascular
Published parties
Registrant / registration holder
Medtronic Hong Kong Medical Limited
Manufacturer
ev3, Inc.
Official description

Stent/Grafts, Vascular

Additional source fields
AMD nomenclature code
18585
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
Published remarks
Delisted.
Revision number
a
Delist date
2025-05-07
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.