Taiwan FDA registration 3ad0f3f53628aad563866b1012d23a55

HelicotecAG H. pylori Antigen Rapid Test Kit (Non-Sterile)

TW: "實創" 胃幽門螺旋桿菌抗原快速檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·MD·STRONG BIOTECH CORP.·Registered May 29, 2018 – May 29, 2028Active

Registration details

Analysis ID: 3ad0f3f53628aad563866b1012d23a55
License Form: Ministry of Health Medical Device Manufacturing No. 007277

Company information

Manufacturer: STRONG BIOTECH CORP.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: STRONG BIOTECH CORP.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C0003 Helicobacter serological reagent
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: May 29, 2018
Expiry Date: May 29, 2028

About this record

Access comprehensive regulatory information for HelicotecAG H. pylori Antigen Rapid Test Kit (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3ad0f3f53628aad563866b1012d23a55 and manufactured by STRONG BIOTECH CORP.. The authorized representative in Taiwan is STRONG BIOTECH CORP..

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