Taiwan FDA registration de5bf5a91043eea5f3bf5741953efef5

Efie Astar Rotavirus Test Reagent (Non-Sterile)

TW: 艾菲雅仕輪狀病毒檢驗試劑(未滅菌)

Taiwan·Risk Class 1·Boditech Med Inc.·Registered Dec 04, 2024 – Dec 04, 2029Active

Registration details

Analysis ID: de5bf5a91043eea5f3bf5741953efef5
Customs Code: DHA09402370308

Company information

Manufacturer: Boditech Med Inc.
Manufacturer Country: Korea, Republic of
Authorized Representative: MEDRICH INSTRUMENT CO., LTD.

Product details

Intended Use: It is limited to the first level of identification scope of the "Poliovirus Serum Reagent (C.3405)" of the Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3405 Poliomyelitis virus serum reagent
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Dec 04, 2024
Expiry Date: Dec 04, 2029

About this record

Access comprehensive regulatory information for Efie Astar Rotavirus Test Reagent (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 de5bf5a91043eea5f3bf5741953efef5 and manufactured by Boditech Med Inc.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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