Pure Global
90342
II
Delisted.

Catheters, Vascular, Angioplasty, Balloonๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Š

This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon. 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

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Š

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
17184
Product Code Detail
17184 Catheters, Vascular, Angioplasty, Balloon
State
Delisted.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Cordis Europa N.V.
Cordis Europa N.V.
Netherlands
่ทๅ…ฐ
Oosteinde 8, 9301 LJ Roden, Netherlands
Oosteinde 8, 9301 LJ ็ฝ—็™ป, ่ทๅ…ฐ
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
ๅผบ็”Ÿ (้ฆ™ๆธฏ) ๆœ‰้™ๅ…ฌๅธ
27386080
Regulatory Timeline
Registration Date
September 02, 2009
Expiry Date
September 02, 2014
Product Models
OPTA PRO Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter (419-0000L, 419-0000S, 419-0000T, 419-0000V, 419-0000X, 419-0000Y, 419-0010L, 419-0010S, 419-0010T, 419-0010V, 419-0010X, 419-0010Y, 419-0015L, 419-0015S, 419-0015T, 419-0015V, 419-0015X, 419-0015Y, 419-0020L, 419-0020S, 419-0020T, 419-0020V, 419-0020X, 419-0020Y, 419-0030L, 419-0030S, 419-0030T, 419-0030V, 419-0030X, 419-0030Y, 419-0040L, 419-0040S, 419-0040T, 419-0040V, 419-0040X, 419-0040Y, 419-0050L, 419-0050S, 419-0050T, 419-0050V, 419-0050X, 419-0050Y, 419-0060L, 419-0060S, 419-0060T, 419-0060V, 419-0060X, 419-0060Y, 419-0070L, 419-0070S, 419-0070T, 419-0070V, 419-0070X, 419-0070Y, 419-0080L, 419-0080S, 419-0080T, 419-0080V, 419-0080X, 419-0080Y, 419-0090L, 419-0090S, 419-0090T, 419-0090V, 419-0090X, 419-0090Y, 419-2010L, 419-2010S, 419-2010T, 419-2010V, 419-2010X, 419-2010Y, 419-2020L, 419-2020S, 419-2020T, 419-2020V, 419-2020X, 419-2020Y, 419-2030L, 419-2030S, 419-2030T, 419-2030V, 419-2030X, 419-2030Y, 419-2040L, 419-2040S, 419-2040T, 419-2040V, 419-2040X, 419-2040Y, 419-3000L, 419-3000S, 419-3000T, 419-3000V, 419-3000X, 419-3000Y, 419-3010L, 419-3010S, 419-3010T, 419-3010V, 419-3010X, 419-3010Y, 419-3015L, 419-3015S, 419-3015T, 419-3015V, 419-3015X, 419-3015Y, 419-3020L, 419-3020S, 419-3020T, 419-3020V, 419-3020X, 419-3020Y, 419-3030L, 419-3030S, 419-3030T, 419-3030V, 419-3030X, 419-3030Y, 419-3040L, 419-3040S, 419-3040T, 419-3040V, 419-3040X, 419-3040Y, 419-3050L, 419-3050S, 419-3050T, 419-3050V, 419-3050X, 419-3050Y, 419-3060L, 419-3060S, 419-3060T, 419-3060V, 419-3060X, 419-3060Y, 419-3070L, 419-3070S, 419-3070T, 419-3070V, 419-3070X, 419-3070Y, 419-3080L, 419-3080S, 419-3080T, 419-3080V, 419-3080X, 419-3080Y, 419-3090L, 419-3090S, 419-3090T, 419-3090V, 419-3090X, 419-3090Y, 419-4000L, 419-4000S, 419-4000T, 419-4000V, 419-4000X, 419-4000Y, 419-4010L, 419-4010S, 419-4010T, 419-4010V, 419-4010X, 419-4010Y, 419-4015L, 419-4015S, 419-4015T, 419-4015V, 419-4015X, 419-4015Y, 419-4020L, 419-4020S, 419-4020T, 419-4020V, 419-4020X, 419-4020Y, 419-4030L, 419-4030S, 419-4030T, 419-4030V, 419-4030X, 419-4030Y, 419-4040L, 419-4040S, 419-4040T, 419-4040V, 419-4040X, 419-4040Y, 419-4050L, 419-4050S, 419-4050T, 419-4050V, 419-4050X, 419-4050Y, 419-4060L, 419-4060S, 419-4060T, 419-4060V, 419-4060X, 419-4060Y, 419-4070L, 419-4070S, 419-4070T, 419-4070V, 419-4070X, 419-4070Y, 419-4080L, 419-4080S, 419-4080T, 419-4080V, 419-4080X, 419-4080Y, 419-4090L, 419-4090S, 419-4090T, 419-4090V, 419-4090X, 419-4090Y, 419-5000L, 419-5000S, 419-5000T, 419-5000V, 419-5000X, 419-5000Y, 419-5010L, 419-5010S, 419-5010T, 419-5010V, 419-5010X, 419-5010Y, 419-5015L, 419-5015S, 419-5015T, 419-5015V, 419-5015X, 419-5015Y, 419-5020L, 419-5020S, 419-5020T, 419-5020V, 419-5020X, 419-5020Y, 419-5030L, 419-5030S, 419-5030T, 419-5030V, 419-5030X, 419-5030Y, 419-5040L, 419-5040S, 419-5040T, 419-5040V, 419-5040X, 419-5040Y, 419-5050L, 419-5050S, 419-5050T, 419-5050V, 419-5050X, 419-5050Y, 419-5060L, 419-5060S, 419-5060T, 419-5060V, 419-5060X, 419-5060Y, 419-5070L, 419-5070S, 419-5070T, 419-5070V, 419-5070X, 419-5070Y, 419-5080L, 419-5080S, 419-5080T, 419-5080V, 419-5080X, 419-5080Y, 419-5090L, 419-5090S, 419-5090T, 419-5090V, 419-5090X, 419-5090Y, 419-6000L, 419-6000S, 419-6000T, 419-6000V, 419-6000X, 419-6000Y, 419-6010L, 419-6010S, 419-6010T, 419-6010V, 419-6010X, 419-6010Y, 419-6015L, 419-6015S, 419-6015T, 419-6015V, 419-6015X, 419-6015Y, 419-6020L, 419-6020S, 419-6020T, 419-6020V, 419-6020X, 419-6020Y, 419-6030L, 419-6030S, 419-6030T, 419-6030V, 419-6030X, 419-6030Y, 419-6040L, 419-6040S, 419-6040T, 419-6040V, 419-6040X, 419-6040Y, 419-6050L, 419-6050S, 419-6050T, 419-6050V, 419-6050X, 419-6050Y, 419-6060L, 419-6060S, 419-6060T, 419-6060V, 419-6060X, 419-6060Y, 419-6070L, 419-6070S, 419-6070T, 419-6070V, 419-6070X, 419-6070Y, 419-6080L, 419-6080S, 419-6080T, 419-6080V, 419-6080X, 419-6080Y, 419-6090L, 419-6090S, 419-6090T, 419-6090V, 419-6090X, 419-6090Y, 419-7000L, 419-7000S, 419-7000T, 419-7000V, 419-7000X, 419-7000Y, 419-7010L, 419-7010S, 419-7010T, 419-7010V, 419-7010X, 419-7010Y, 419-7015L, 419-7015S, 419-7015T, 419-7015V, 419-7015X, 419-7015Y, 419-7020L, 419-7020S, 419-7020T, 419-7020V, 419-7020X, 419-7020Y, 419-7030L, 419-7030S , 419-7030T , 419-7030V, 419-7030X, 419-7030Y , 419-7040L, 419-7040S, 419-7040T, 419-7040V, 419-7040X, 419-7040Y, 419-7050L, 419-7050S, 419-7050T, 419-7050V, 419-7050X, 419-7050Y, 419-7060L, 419-7060S, 419-7060T, 419-7060V, 419-7060X, 419-7060Y, 419-7070L, 419-7070S, 419-7070T, 419-7070V, 419-7070X, 419-7070Y, 419-7080L, 419-7080S, 419-7080T, 419-7080V, 419-7080X, 419-7080Y, 419-7090L, 419-7090S, 419-7090T, 419-7090V, 419-7090X, 419-7090Y, 419-8000L, 419-8000S, 419-8000T, 419-8000V, 419-8000X, 419-8000Y, 419-8010L, 419-8010S, 419-8010T, 419-8010V, 419-8010X, 419-8010Y, 419-8015L, 419-8015S, 419-8015T, 419-8015V, 419-8015X, 419-8015Y, 419-8020L, 419-8020S, 419-8020T, 419-8020V, 419-8020X, 419-8020Y, 419-8030L, 419-8030S , 419-8030T , 419-8030V , 419-8030X , 419-8030Y , 419-8040L, 419-8040S, 419-8040T, 419-8040V, 419-8040X, 419-8040Y, 419-8050L, 419-8050S, 419-8050T, 419-8050V, 419-8050X, 419-8050Y, 419-8060L, 419-8060S, 419-8060T, 419-8060V, 419-8060X, 419-8060Y, 419-8070L, 419-8070S, 419-8070T, 419-8070V, 419-8070X, 419-8070Y, 419-8080L, 419-8080S, 419-8080T, 419-8080V, 419-8080X, 419-8080Y, 419-8090L, 419-8090S, 419-8090T, 419-8090V, 419-8090X, 419-8090Y, 419-9000L, 419-9000S, 419-9000T, 419-9000V, 419-9000X, 419-9000Y, 419-9010L, 419-9010S, 419-9010T, 419-9010V, 419-9010X, 419-9010Y, 419-9015L, 419-9015S, 419-9015T, 419-9015V, 419-9015X, 419-9015Y, 419-9020L, 419-9020S, 419-9020T, 419-9020V, 419-9020X, 419-9020Y, 419-9030L, 419-9030S , 419-9030T , 419-9030V , 419-9030X , 419-9030Y , 419-9040L, 419-9040S, 419-9040T, 419-9040V, 419-9040X, 419-9040Y, 419-9050L, 419-9050S, 419-9050T, 419-9050V, 419-9050X, 419-9050Y, 419-9060L, 419-9060S, 419-9060T, 419-9060V, 419-9060X, 419-9060Y, 419-9070L, 419-9070S, 419-9070T, 419-9070V, 419-9070X, 419-9070Y, 419-9080L, 419-9080S, 419-9080T, 419-9080V, 419-9080X, 419-9080Y, 419-9090L, 419-9090S, 419-9090T, 419-9090V, 419-9090X, 419-9090Y)\n
OPTA PRO ็ป็šฎ่…”ๅ†…่ก€็ฎกๆˆๅฝขๆœฏ (PTA) ็ƒๅ›Šๆ‰ฉๅผ ๅฏผ็ฎก(419-0000Lใ€419-0000Sใ€419-0000Tใ€419-0000Vใ€419-0000Xใ€419-0000Yใ€419-0010Lใ€419-0010Sใ€419-0010Tใ€419-0010Vใ€419-0010Xใ€419-0010Yใ€419-0015Lใ€419-0015Sใ€419-0015Tใ€419-0015Vใ€419-0015Xใ€419-0015X 19-0015Y, 419-0020L, 419-0020S, 419-0020T, 419-0020V, 419-0020X, 419-0020Y, 419-0030L, 419-0030S, 419-0030T, 419-0030V, 419-0030X, 419-0030Y, 419-0040L, 419-0040S, 419-0040T, 419-0040V, 419-0040X, 419-0040Y, 419-0050L,419-0050S, 419-0050T, 419-0050V, 419-0050X, 419-0050Y, 419-0060L, 419-0060S, 419-0060T, 419-0060V, 419-0060X, 419-0060Y, 419-0070L, 419-0070S, 419-0070T, 419-0070V, 419-0070X, 419-0070Y, 419-0080L, 419-0080S, 419-0080T, 419-0080V, 419-0080X, 419-0080X, 419-000 80Yใ€419-0090Lใ€419-0090Sใ€419-0090Tใ€419-0090Vใ€419-0090Xใ€419-0090Yใ€419-2010Lใ€419-2010Sใ€419-2010Tใ€419-2010Vใ€419-2010Xใ€419-2010Yใ€419-2020Lใ€419-2020Sใ€419-2020Tใ€419-2020Vใ€419-2020Xใ€419-2020Yใ€419-2030Lใ€419-2030Sใ€419-2030Tใ€419-2030Vใ€ 419-2030X, 419-2030Y, 419-2040L, 419-2040S, 419-2040T, 419-2040V, 419-2040X, 419-2040Y, 419-3000L, 419-3000S, 419-3000T, 419-3000V, 419-3000X, 419-3000Y, 419-3010L, 419-3010S, 419-3010T, 419-3010V, 419-3010X, 419-3010Y, 419-3015L, 419-3015S, 419-3015S, 419-30 15Tใ€419-3015Vใ€419-3015Xใ€419-3015Yใ€419-3020Lใ€419-3020Sใ€419-3020Tใ€419-3020Vใ€419-3020Xใ€419-3020Yใ€419-3030Lใ€419-3030Sใ€419-3030Tใ€419-3030Vใ€419-3030Xใ€419-3030Yใ€419-3040Lใ€419-3040Sใ€419-3040Tใ€419-3040Vใ€419-3040Xใ€419-3040Yใ€419-3050Lใ€ 419-3050S, 419-3050T, 419-3050V, 419-3050X, 419-3050Y, 419-3060L, 419-3060S, 419-3060T, 419-3060V, 419-3060X, 419-3060Y, 419-3070L, 419-3070S, 419-3070T, 419-3070V, 419-3070X, 419-3070Y, 419-3080L, 419-3080S, 419-3080T, 419-3080V, 419-3080X, 419-3080X, 419-30 80Yใ€419-3090Lใ€419-3090Sใ€419-3090Tใ€419-3090Vใ€419-3090Xใ€419-3090Yใ€419-4000Lใ€419-4000Sใ€419-4000Tใ€419-4000Vใ€419-4000Xใ€419-4000Yใ€419-4010Lใ€419-4010Sใ€419-4010Tใ€419-4010Vใ€419-4010Xใ€419-4010Yใ€419-4015Lใ€419-4015Sใ€419-4015Tใ€419-4015Vใ€ 419-4015X, 419-4015Y, 419-4020L, 419-4020S, 419-4020T, 419-4020V, 419-4020X, 419-4020Y, 419-4030L, 419-4030S, 419-4030T, 419-4030V, 419-4030X, 419-4030Y, 419-4040L, 419-4040S, 419-4040T, 419-4040V, 419-4040X, 419-4040Y, 419-4050L, 419-4050S, 419-400 50Tใ€419-4050Vใ€419-4050Xใ€419-4050Yใ€419-4060Lใ€419-4060Sใ€419-4060Tใ€419-4060Vใ€419-4060Xใ€419-4060Yใ€419-4070Lใ€419-4070Sใ€419-4070Tใ€419-4070Vใ€419-4070Xใ€419-4070Yใ€419-4080Lใ€419-4080Sใ€419-4080Tใ€419-4080Vใ€419-4080Xใ€419-4080Yใ€419-4090Lใ€ 419-4090S, 419-4090T, 419-4090V, 419-4090X, 419-4090Y, 419-5000L, 419-5000S, 419-5000T, 419-5000V, 419-5000X, 419-5000Y, 419-5010L, 419-5010S, 419-5010T, 419-5010V, 419-5010X, 419-5010Y, 419-5015L, 419-5015S, 419-5015T, 419-5015V, 419-5015X, 419-5015V, 419-5015X, 419-500 15Y, 419-5020L, 419-5020S, 419-5020T, 419-5020V, 419-5020X, 419-5020Y, 419-5030L, 419-5030S, 419-5030T, 419-5030V, 419-5030X, 419-5030Y, 419-5040L, 419-5040S, 419-5040T, 419-5040V, 419-5040X, 419-5040Y, 419-5050L, 419-5050S, 419-5050T, 419-5050V, 419-5050X, 419-5050Y, 419-5060L, 419-5060S, 419-5060T, 419-5060V, 419-5060X, 419-5060Y, 419-5070L, 419-5070S, 419-5070T, 419-5070V, 419-5070X, 419-5070Y, 419-5080L, 419-5080S, 419-5080T, 419-5080V, 419-5080X, 419-5080Y, 419-5090L, 419-5090S, 419-5090S, 419-500 90Tใ€419-5090Vใ€419-5090Xใ€419-5090Yใ€419-6000Lใ€419-6000Sใ€419-6000Tใ€419-6000Vใ€419-6000Xใ€419-6000Yใ€419-6010Lใ€419-6010Sใ€419-6010Tใ€419-6010Vใ€419-6010Xใ€419-6010Yใ€419-6015Lใ€419-6015Sใ€419-6015Tใ€419-6015Vใ€419-6015Xใ€419-6015Yใ€419-6020Lใ€ 419-6020S, 419-6020T, 419-6020V, 419-6020X, 419-6020Y, 419-6030L, 419-6030S, 419-6030T, 419-6030V, 419-6030X, 419-6030Y, 419-6040L, 419-6040S, 419-6040T, 419-6040V, 419-6040X, 419-6040Y, 419-6050L, 419-6050S, 419-6050T, 419-6050V, 419-6050X, 419-6050X, 419-60 50Yใ€419-6060Lใ€419-6060Sใ€419-6060Tใ€419-6060Vใ€419-6060Xใ€419-6060Yใ€419-6070Lใ€419-6070Sใ€419-6070Tใ€419-6070Vใ€419-6070Xใ€419-6070Yใ€419-6080Lใ€419-6080Sใ€419-6080Tใ€419-6080Vใ€419-6080Xใ€419-6080Yใ€419-6090Lใ€419-6090Sใ€419-6090Tใ€419-6090Vใ€ 419-6090X, 419-6090Y, 419-7000L, 419-7000S, 419-7000T, 419-7000V, 419-7000X, 419-7000Y, 419-7010L, 419-7010S, 419-7010T, 419-7010V, 419-7010X, 419-7010Y, 419-7015L, 419-7015S, 419-7015T, 419-7015V, 419-7015X, 419-7015Y, 419-7020L, 419-7020S, 419-7020S, 419-7015S, 419-7015V 20T, 419-7020V, 419-7020X, 419-7020Y, 419-7030L, 419-7030S, 419-7030T, 419-7030V, 419-7030X, 419-7030Y, 419-7040L, 419-7040S, 419-7040T, 419-7040V, 419-7040X, 419-7040Y, 419-7050L, 419-7050S, 419-7050T, 419-7050V, 419-7050X, 419-7050Y, 419-7060L, 419-7060S, 419-7060T, 419-7060V, 419-7060X, 419-7060Y, 419-7070L, 419-7070S, 419-7070T, 419-7070V, 419-7070X, 419-7070Y, 419-7080L, 419-7080S, 419-7080T, 419-7080V, 419-7080X, 419-7080Y, 419-7090L, 419-7090S, 419-7090T, 419-7090V, 419-7090X, 419-7090V, 419-7090X, 419-7090X, 419-70 90Yใ€419-8000Lใ€419-8000Sใ€419-8000Tใ€419-8000Vใ€419-8000Xใ€419-8000Yใ€419-8010Lใ€419-8010Sใ€419-8010Tใ€419-8010Vใ€419-8010Xใ€419-8010Yใ€419-8015Lใ€419-8015Sใ€419-8015Tใ€419-8015Vใ€419-8015Xใ€419-8015Yใ€419-8020Lใ€419-8020Sใ€419-8020Tใ€419-8020Vใ€ 419-8020X, 419-8020Y, 419-8030L, 419-8030S, 419-8030T, 419-8030V, 419-8030X , 419-8030Y , 419-8040L, 419-8040S, 419-8040T, 419-8040V, 419-8040X, 419-8040Y, 419-8050L, 419-8050S, 419-8050T, 419-8050V, 419-8050X, 419-8050Y, 419-8060L, 419-8060S, 419-8060S, 419-8050S, 419-8060S, 419-8060S, 419-8050S, 419-8060S, 419-8060S, 419-8050S, 419-8060S, 419-8060S, 419-8050S, 419-8050S, 419-8060S, 419-8060S, 419-8050S, 419-8060S, 419-8060S, 419-8050S, 419-8050S, 419-8050X, 419-8050Y, 419-8060L, 419-8060S, 419-8060S, 419-8060S, 419-8050S, 419-8050S, 419-8050X, 419-8050V, 419-8050X, 419-8050Y, 419-8060L, 419-8060S, 419-8060S, 419-8060S, 419-8050S, 419-8050S, 419-8050V, 419-8050X, 419-8050Y, 419-8060L, 419-8060S, 419-8060S, 419-8060S, 419-8050S, 419-8050S, 060T, 419-8060V, 419-8060X, 419-8060Y, 419-8070L, 419-8070S, 419-8070T, 419-8070V, 419-8070X, 419-8070Y, 419-8080L, 419-8080S, 419-8080T, 419-8080V, 419-8080X, 419-8080Y, 419-8090L, 419-8090S, 419-8090T, 419-8090V, 419-8090X, 419-8090Y, 419-9000L, 419-9000S, 419-9000T, 419-9000V, 419-9000X, 419-9000Y, 419-9010L, 419-9010S, 419-9010T, 419-9010V, 419-9010X, 419-9010Y, 419-9015L, 419-9015S, 419-9015T, 419-9015V, 419-9015X, 419-9015Y, 419-9020L, 419-9020S, 419-9020T, 419-9020V, 419-9020X, 419-900 20Y, 419-9030L, 419-9030S , 419-9030T , 419-9030V , 419-9030X , 419-9030Y , 419-9040L, 419-9040S, 419-9040T, 419-9040V, 419-9040X, 419-9040Y, 419-9050L, 419-9050S, 419-9050T, 419-9050V, 419-9050X, 419-9050Y, 419-9060L, 419-9060S, 419-9060T, 419-9060V, 419-9060X, 419-9060Y, 419-9070L, 419-9070S, 419-9070T, 419-9070V, 419-9070X, 419-9070Y, 419-9080L, 419-9080S, 419-9080T, 419-9080V, 419-9080X, 419-9080Y, 419-9090L, 419-9090S, 419-9090T, 419-9090V, 419-9090X, 419-9090Y)\n