Taiwan FDA registration 4073b7619635d780ab5b324dfd4f46fa

"iVac" rapid hemoglobin test system

TW: "易凱福" 快速血色素測試系統

Taiwan·Risk Class 2·EKF-DIAGNOSTIC GMBH·Registered Dec 19, 2005 – Dec 19, 2015Cancelled

Registration details

Analysis ID: 4073b7619635d780ab5b324dfd4f46fa
Customs Code: DHA00601568701

Company information

Manufacturer: EKF-DIAGNOSTIC GMBH
Manufacturer Country: Germany
Authorized Representative: Y.H. BIOTEK CO., LTD.

Product details

Intended Use: Hemo_Control_system rapid and accurate determination of hemoglobin in blood, including a handheld photometer and a dry chemical reagent microcolorimeter, a small amount of blood from veins, arteries or microvessels is inhaled into a microcolorimetric tube by capillary action, put into a Hemo_Control photometer, and a chemical reaction is generated in the microcolorimetric tube, and its color is automatically measured to display the hemoglobin value.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.5620 Automated Heme Analysis System
Import Information: import

Dates and status

Registration Date: Dec 19, 2005
Expiry Date: Dec 19, 2015
Cancellation Date: Jun 28, 2018

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "iVac" rapid hemoglobin test system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4073b7619635d780ab5b324dfd4f46fa and manufactured by EKF-DIAGNOSTIC GMBH. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..

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