Taiwan FDA registration dd62a1f46829a9d4d0774a97483b695c

"Real Wound" Gastric Helicobacter pylori Antigen Rapid Test Reagent (Non-sterilized)

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·STRONG BIOTECH CORP.·Registered Nov 08, 2023 – Nov 08, 2028Active

Registration details

Analysis ID: dd62a1f46829a9d4d0774a97483b695c

Company information

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

Product details

Intended Use: Limited to the classification and grading management of medical devices, the first level identification range of "Helicobacter serum reagent (C.0003)".
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.0003 螺旋桿菌屬血清試劑
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Nov 08, 2023
Expiry Date: Nov 08, 2028

About this record

Access comprehensive regulatory information for "Real Wound" Gastric Helicobacter pylori Antigen Rapid Test Reagent (Non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number dd62a1f46829a9d4d0774a97483b695c and manufactured by STRONG BIOTECH CORP.. The authorized representative in Taiwan is STRONG BIOTECH CORP..

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