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Medical Device Division · registration 180312Active

BrosMed Medical

Hong KongCatheters, Vascular, Angioplasty, Balloon, CoronaryClass IVBrosMed Medical Co., Ltd
Official record identity
MDACS listing number
180312
Model name
Artimes Balloon Dilatation Catheter (801-1005, 801-1008, 801-1010, 801-1012, 801-1015, 801-1020, 801-1025, 801-1030 801-1205, 801-1208, 801-1210, 801-1212, 801-1215, 801-1220, 801-1225, 801-1230 801-1505, 801-1508, 801-1510, 801-1512, 801-1515, 801-1520, 801-1525, 801-1530 801-1705, 801-1708, 801-1710, 801-1712, 801-1715, 801-1720, 801-1725, 801-1730 801-2005, 801-2008, 801-2010, 801-2012, 801-2015, 801-2020, 801-2025, 801-2030 801-2205, 801-2208, 801-2210, 801-2212, 801-2215, 801-2220, 801-2225, 801-2230 801-2505, 801-2508, 801-2510, 801-2512, 801-2515, 801-2520, 801-2525, 801-2530 801-2705, 801-2708, 801-2710, 801-2712, 801-2715, 801-2720, 801-2725, 801-2730 801-3005, 801-3008, 801-3010, 801-3012, 801-3015, 801-3020, 801-3025, 801-3030 801-3205, 801-3208, 801-3210, 801-3212, 801-3215, 801-3220, 801-3225, 801-3230 801-3505, 801-3508, 801-3510, 801-3512, 801-3515, 801-3520, 801-3525, 801-3530 801-3705, 801-3708, 801-3710, 801-3712, 801-3715, 801-3720, 801-3725, 801-3730 801-4005, 801-4008, 801-4010, 801-4012, 801-4015, 801-4020, 801-4025, 801-4030)
Registration date
February 08, 2023
Expiry date
August 22, 2028
Source update date
September 20, 2024
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Catheters, Vascular, Angioplasty, Balloon, Coronary
Published parties
Registrant / registration holder
Angeion Medical HK Limited
Official description

Catheters, Vascular, Angioplasty, Balloon, Coronary

Additional source fields
AMD nomenclature code
34313
Traditional Chinese local responsible person
安健醫療香港有限公司
Local responsible person phone
97761625
Published manufacturer address
15th Building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone, Dongguan, Guangdong, 523808, 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.