Taiwan FDA registration 5e73800d4fab0641cc2d21d4f796067c
Formosa One Sure MDMA rapid test kit
TW: 台塑生醫迅知3,4-亞甲基雙氧甲基安非他命(搖頭丸)快速檢驗試劑
Taiwan·Risk Class 2·MD·Formosa Biomedical Technology Co., Ltd. Yilan Factory·Registered May 22, 2019 – May 22, 2024ExpiredRegistration details
- Analysis ID
- 5e73800d4fab0641cc2d21d4f796067c
- License Form
- Ministry of Health Medical Device Manufacturing No. 006297
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION
Product details
- Intended Use
- This product uses competitive immunochromatography to qualitatively detect 3,4-methylenedioxymethamphetamine (ecstasy) in human urine, and the test results can only be used for preliminary screening. The threshold standard for ecstasy is 500 ng/mL. This product can be used by both individuals and professionals.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A3610 Methamphetamine Test System
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- May 22, 2019
- Expiry Date
- May 22, 2024
About this record
Access comprehensive regulatory information for Formosa One Sure MDMA rapid test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5e73800d4fab0641cc2d21d4f796067c and manufactured by Formosa Biomedical Technology Co., Ltd. Yilan Factory. The authorized representative in Taiwan is FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION.
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