Taiwan FDA registration 51e4e99a0e96b97ca7372dab1b3444f4

"ACRO" Mycoplasma Pneumoniae Rapid Test (Non-Sterile)

TW: "艾快露" 肺炎黴漿菌檢測試劑 (未滅菌)

Taiwan·Risk Class 1·MD·ACRO BIOTECH. INC.·Registered Sep 10, 2016 – Sep 10, 2026Active

Registration details

Analysis ID: 51e4e99a0e96b97ca7372dab1b3444f4
License Form: Ministry of Health Medical Device Import No. 016993
Customs Code: DHA09401699300

Company information

Manufacturer: ACRO BIOTECH. INC.
Manufacturer Country: United States
Authorized Representative: Grand Marquis IVD CO., LTD.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Mycoplasma Serological Reagent (C.3375)".
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3375 Mycoplasma serum reagent
Import Information: Imported from abroad

Dates and status

Registration Date: Sep 10, 2016
Expiry Date: Sep 10, 2026

About this record

Access comprehensive regulatory information for "ACRO" Mycoplasma Pneumoniae Rapid Test (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 51e4e99a0e96b97ca7372dab1b3444f4 and manufactured by ACRO BIOTECH. INC.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

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