Vietnam MOH registration 2403133ĐKLH/BYT-HTTB

Activated Partial Thromboplastin Time (aPTT) Test

VN: Bộ xét nghiệm xác định thời gian đông máu hoạt hóa của máu toàn phần
Vietnam flagVietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Medtronic Plc·Registered Nov 02, 2024
Registration details
Analysis ID
2403133ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-210611-0005
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer
Medtronic Plc
Manufacturer Country
Theo theo phụ lục
Product Owner
Medtronic Plc
Authorized Representative
CÔNG TY TNHH MEDTRONIC VIỆT NAM
Technical details
Intended Use
Cartridge, LR-ACT; Cartridge, RACT; Cartridge, HR-ACT: Used to determine the activated partial thromboplastin time (aPTT). Used for in vitro diagnosis. Cartridge, HR HTC, Boxed: Used to determine the presence of heparin by the activated partial thromboplastin time (aPTT). Used for in vitro diagnosis. Caution: Due to the specific characteristics of this product, it is important to ensure that heparinase does not inadvertently transfer from the "HR HTC" channel to the "HR" channel of the cartridge.
Dates and status
Registration Date
Nov 02, 2024
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About this record

Access comprehensive regulatory information for Activated Partial Thromboplastin Time (aPTT) Test 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 2403133ĐKLH/BYT-HTTB and manufactured by Medtronic Plc. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Roche Diagnostics GmbH, 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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