Taiwan FDA registration c113595539037a790d60263ed90ce239

EASEmed Ketamine (KET) Rapid Test Kit

TW: 醫試美愷他命快速檢驗試劑

Taiwan·Risk Class 2·MD·Kaiwu Technology Co., Ltd. Nanke Factory·Registered Jan 09, 2014 – Jan 09, 2029Active

Registration details

Analysis ID: c113595539037a790d60263ed90ce239
License Form: Ministry of Health Medical Device Manufacturing No. 004431

Company information

Manufacturer: Kaiwu Technology Co., Ltd. Nanke Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Kaiwu Technology Co., Ltd. Nanke Factory

Product details

Intended Use: This product is a qualitative detection of kaitazine and its metabolites in human urine, and its threshold concentration is 100ng/mL. Performance Change (Correction): This product is a qualitative test of katamine and its metabolites in human urine at a threshold concentration of 100 ng/mL. This product can be used by professionals and general personnel.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A0001 Phencyclidine Test System
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Jan 09, 2014
Expiry Date: Jan 09, 2029

About this record

Access comprehensive regulatory information for EASEmed Ketamine (KET) 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 c113595539037a790d60263ed90ce239 and manufactured by Kaiwu Technology Co., Ltd. Nanke Factory. The authorized representative in Taiwan is Kaiwu Technology Co., Ltd. Nanke Factory.

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