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Elite Innyl Repair 2nd generation prothrombin time/international standard ratio professional monitoring system - Taiwan Registration 7e426b9f83c35d75a677e8b35074d5cc

Access comprehensive regulatory information for Elite Innyl Repair 2nd generation prothrombin time/international standard ratio professional monitoring system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7e426b9f83c35d75a677e8b35074d5cc and manufactured by ALERE SAN DIEGO, INC.. The authorized representative in Taiwan is Ariel Health Inc.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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7e426b9f83c35d75a677e8b35074d5cc
Registration Details
Taiwan FDA Registration: 7e426b9f83c35d75a677e8b35074d5cc
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Device Details

Elite Innyl Repair 2nd generation prothrombin time/international standard ratio professional monitoring system
TW: ็พŽ่‰พๅˆฉ็ˆพๅ› ่Šฎไฟฎ็ฌฌไบŒไปฃๅ‡่ก€้…ถๅŽŸๆ™‚้–“/ๅœ‹้š›ๆจ™ๆบ–ๆฏ”ๅ€ผๅฐˆๆฅญๅž‹็›ฃๆŽง็ณป็ตฑ
Risk Class 2
Cancelled

Registration Details

7e426b9f83c35d75a677e8b35074d5cc

DHA00602168305

Company Information

United States

Product Details

The INRatio2 PT monitoring system quantifies coagulation time (PT) in fresh capillary whole blood. The INRatio2 PT monitoring system is for in vitro diagnostic use only and is intended for patients on warfarin and other oral anticoagulant (hemodilution) therapies to monitor the clotting time of their blood. The INRatio2 PT monitoring system should not be used for screening purposes.

B Hematology, pathology, and genetics

B.7750 Prothrombin time test

import

Dates and Status

Nov 09, 2010

Nov 09, 2020

Sep 01, 2017

Cancellation Information

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