241015
IV
current
Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery导管、血管、血管成形术、球囊、外周动脉、药物输送
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery
產品資訊： 导管、血管、血管成形术、球囊、外周动脉、药物输送
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
34320
Product Code Detail
34320 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery
State
current
Status
N/A
Manufacturer (製造商)
Concept Medical B.V.
Concept Medical B.V.
Netherlands
荷兰
Hogebrinkerweg 33, 3871KM Hoevelaken, The Netherlands
Hogebrinkerweg 33, 3871KM Hoevelaken, 荷兰
Authorised Representative (AR)
Angeion Medical HK Limited
安健医疗香港有限公司
96886105
Regulatory Timeline
Registration Date
August 29, 2024
Expiry Date
August 28, 2029
Product Models
Magic Touch AVF Sirolimus Coated PTA Balloon Catheter (CMFW35001, CMFW35002, CMFW35003, CMFW35004, CMFW35005, CMFW35006, CMFW35007, CMFW35008, CMFW35009, CMFW35010, CMFW35011, CMFW35012, CMFW35013, CMFW35014, CMFW35015, CMFW35016, CMFW35017, CMFW35018, CMFW35019, CMFW35020, CMFW35021, CMFW35022, CMFW35023, CMFW35024, CMFW35025, CMFW35026, CMFW35027, CMFW35028, CMFW35029, CMFW35030, CMFW35031, CMFW35032, CMFW35033, CMFW35034, CMFW35035, CMFW35036, CMFW35037, CMFW35038, CMFW35039, CMFW35040, CMFW35041, CMFW35042, CMFW35043, CMFW35044, CMFW35045, CMFW35046, CMFW35047, CMFW35048, CMFW35049, CMFW35050, CMFW35051, CMFW35052, CMFW35053, CMFW35054, CMFW35055, CMFW35056, CMFW35057, CMFW35058, CMFW35059, CMFW35060, CMFW35061, CMFW35062, CMFW35063, CMFW35064, CMFW35065, CMFW35066, CMFW35067, CMFW35068, CMFW35069, CMFW35070, CMFW35071, CMFW35072, CMFW35073, CMFW35074, CMFW35075, CMFW35076, CMFW35077, CMFW35078, CMFW35079, CMFW35080, CMFW35081, CMFW35082, CMFW35083, CMFW35084, CMFW35085, CMFW35086, CMFW35087, CMFW35088, CMFW35089, CMFW35090, CMFW35091, CMFW35092, CMFW35093, CMFW35094, CMFW35095, CMFW35096, CMFW35097, CMFW35098, CMFW35099, CMFW35100, CMFW35101, CMFW35102, CMFW35103, CMFW35104, CMFW35105, CMFW35106, CMFW35107, CMFW35108, CMFW35109, CMFW35110, CMFW35111, CMFW35112, CMFW35113, CMFW35114, CMFW35115, CMFW35116, CMFW35117, CMFW35118, CMFW35119, CMFW35120, CMFW35121, CMFW35122, CMFW35123, CMFW35124, CMFW35125, CMFW35126, CMFW35127, CMFW35128, CMFW35129, CMFW35130, CMFW35131, CMFW35132, CMFW35133, CMFW35134, CMFW35135, CMFW35136, CMFW35137, CMFW35138, CMFW35139, CMFW35140, CMFW35141, CMFW35142, CMFW35143, CMFW35144, CMFW35145, CMFW35146, CMFW35147, CMFW35148, CMFW35149, CMFW35150, CMFW35151, CMFW35152, CMFW35153, CMFW35154, CMFW35155, CMFW35156, CMFW35157, CMFW35158, CMFW35159, CMFW35160, CMFW35161, CMFW35162, CMFW35163, CMFW35164, CMFW35165, CMFW35166, CMFW35167, CMFW35168, CMFW35169, CMFW35170, CMFW35171, CMFW35172, CMFW35173, CMFW35174, CMFW35175, CMFW35176, CMFW35177, CMFW35178, CMFW35179, CMFW35180, CMFW35181, CMFW35182, CMFW35183, CMFW35184, CMFW35185, CMFW35186, CMFW35187, CMFW35188, CMFW35189, CMFW35190, CMFW35191, CMFW35192, CMFW35193, CMFW35194, CMFW35195, CMFW35196, CMFW35197, CMFW35198, CMFW35199, CMFW35200, CMFW35201, CMFW35202, CMFW35203, CMFW35204, CMFW35205, CMFW35206, CMFW35207, CMFW35208, CMFW35209, CMFW35210, CMFW35211, CMFW35212, CMFW35213, CMFW35214, CMFW35215, CMFW35216, CMFW35217, CMFW35218, CMFW35219, CMFW35220, CMFW35221, CMFW35222, CMFW35223, CMFW35224, CMFW35225, CMFW35226, CMFW35227, CMFW35228, CMFW35229, CMFW35230, CMFW35231, CMFW35232, CMFW35233, CMFW35234, CMFW35235, CMFW35236, CMFW35237, CMFW35238, CMFW35239, CMFW35240, CMFW35241, CMFW35242, CMFW35243, CMFW35244, CMFW35245, CMFW35246, CMFW35247, CMFW35248, CMFW35249, CMFW35250, CMFW35251, CMFW35252, CMFW35253, CMFW35254, CMFW35255, CMFW35256, CMFW35257, CMFW35258, CMFW35259, CMFW35260, CMFW35261, CMFW35262, CMFW35263, CMFW35264)
Magic Touch AVF 西罗莫司涂层 PTA 球囊导管(CMFW35001、CMFW35002、CMFW35003、CMFW35004、CMFW35005、CMFW35006、CMFW35007、CMFW35008、CMFW35009、CMFW35010、CMFW35011、CMFW35012、CMFW35013、CMFW35014、CMFW35015、CMFW35016、CMFW35017、CMFW35018、CMFW35019、CMFW35020、CMFW35021、CMFW35022、CMFW35023、CMFW35024、CMFW35025、CMFW35026、CMFW35027、CMFW35028、CMFW35029、CMFW35030、CMFW35031、CMFW35032、CMFW35033、CMFW35034、CMFW35035、CMFW35036、CMFW35037、CMFW35038、CMFW35039、CMFW35040、 CMFW35041、CMFW35042、CMFW35043、CMFW35044、CMFW35045、CMFW35046、CMFW35047、CMFW35048、CMFW35049、CMFW35050、CMFW35051、CMFW35052、CMFW35053、CMFW35054、CMFW35055、CMFW35056、CMFW35057、CMFW35058、CMFW35059、CMFW35060、CMFW35061、CMFW35062、CMFW35063、CMFW35064、CMFW35065、CMFW35066、CMFW35067、CMFW35068、CMFW35069、CMFW35070、CMFW35071、CMFW35072、CMFW35073、CMFW35074、CMFW35075、CMFW35076、CMFW35077、CMFW35078、CMFW35079、CMFW35080、CMFW35081、CMFW35082、CMFW35083、CMFW35084、CMFW35085、 CMFW35086、CMFW35087、CMFW35088、CMFW35089、CMFW35090、CMFW35091、CMFW35092、CMFW35093、CMFW35094、CMFW35095、CMFW35096、CMFW35097、CMFW35098、CMFW35099、CMFW35100、CMFW35101、CMFW35102、CMFW35103、CMFW35104、CMFW35105、CMFW35106、CMFW35107、CMFW35108、CMFW35109、CMFW35110、CMFW35111、CMFW35112、CMFW35113、CMFW35114、CMFW35115、CMFW35116、CMFW35117、CMFW35118、CMFW35119、CMFW35120、CMFW35121、CMFW35122、CMFW35123、CMFW35124、CMFW35125、CMFW35126、CMFW35127、CMFW35128、CMFW35129、CMFW35130、 CMFW35131、CMFW35132、CMFW35133、CMFW35134、CMFW35135、CMFW35136、CMFW35137、CMFW35138、CMFW35139、CMFW35140、CMFW35141、CMFW35142、CMFW35143、CMFW35144、CMFW35145、CMFW35146、CMFW35147、CMFW35148、CMFW35149、CMFW35150、CMFW35151、CMFW35152、CMFW35153、CMFW35154、CMFW35155、CMFW35156、CMFW35157、CMFW35158、CMFW35159、CMFW35160、CMFW35161、CMFW35162、CMFW35163、CMFW35164、CMFW35165、CMFW35166、CMFW35167、CMFW35168、CMFW35169、CMFW35170、CMFW35171、CMFW35172、CMFW35173、CMFW35174、CMFW35175、 CMFW35176、CMFW35177、CMFW35178、CMFW35179、CMFW35180、CMFW35181、CMFW35182、CMFW35183、CMFW35184、CMFW35185、CMFW35186、CMFW35187、CMFW35188、CMFW35189、CMFW35190、CMFW35191、CMFW35192、CMFW35193、CMFW35194、CMFW35195、CMFW35196、CMFW35197、CMFW35198、CMFW35199、CMFW35200、CMFW35201、CMFW35202、CMFW35203、CMFW35204、CMFW35205、CMFW35206、CMFW35207、CMFW35208、CMFW35209、CMFW35210、CMFW35211、CMFW35212、CMFW35213、CMFW35214、CMFW35215、CMFW35216、CMFW35217、CMFW35218、CMFW35219、CMFW35220、 CMFW35221、CMFW35222、CMFW35223、CMFW35224、CMFW35225、CMFW35226、CMFW35227、CMFW35228、CMFW35229、CMFW35230、CMFW35231、CMFW35232、CMFW35233、CMFW35234、CMFW35235、CMFW35236、CMFW35237、CMFW35238、CMFW35239、CMFW35240、CMFW35241、CMFW35242、CMFW35243、CMFW35244、CMFW35245、CMFW35246、CMFW35247、CMFW35248、CMFW35249、CMFW35250、CMFW35251、CMFW35252、CMFW35253、CMFW35254、CMFW35255、CMFW35256、CMFW35257、CMFW35258、CMFW35259、CMFW35260、CMFW35261、CMFW35262、CMFW35263、CMFW35264)