Vietnam MOH registration 2401060ĐKLH/BYT-HTTB

Extracorporeal Shockwave Lithotripsy Catheter

VN: Ống thông tán sỏi nội mạch ngoại vi
Vietnam flagVietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Shockwave Medical, Inc.·Registered Jul 21, 2024
Registration details
Analysis ID
2401060ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-201218-0002
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Product Owner
Shockwave Medical, Inc.
Authorized Representative
CÔNG TY TNHH ARQON VIỆT NAM
Technical details
Intended Use
The IVL Peripheral Shockwave M5 System is indicated for the treatment of calcified, in-stent restenosis in the peripheral arteries of suitable patients, as an alternative to surgical bypass.
Dates and status
Registration Date
Jul 21, 2024
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About this record

Access comprehensive regulatory information for Extracorporeal Shockwave Lithotripsy Catheter in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2401060ĐKLH/BYT-HTTB and manufactured by Shockwave Medical, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ARQON VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Shockwave Medical, Inc., and 1 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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