Taiwan FDA registration 4b8eeb44609e6358499814225fe05910
Arkray Factory Blood Glucose Control Solution (Non-Sterile)
TW: 艾科來血糖品管液 (未滅菌)
Registration details
- Analysis ID
- 4b8eeb44609e6358499814225fe05910
- License Form
- Ministry of Health Medical Device Import No. 021789
- Customs Code
- DHA09402178908
Company information
- Manufacturer
- ARKRAY FACTORY, INC.
- Manufacturer Country
- Japan
- Authorized Representative
- AMESDATA BIOTECH CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of quality control materials (analytical and non-analytical) (A.1660) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1660 Quality Control Materials (Analytical and Non-Analytical)
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 27, 2020
- Expiry Date
- Jul 27, 2025
About this record
Access comprehensive regulatory information for Arkray Factory Blood Glucose Control Solution (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 4b8eeb44609e6358499814225fe05910 and manufactured by ARKRAY FACTORY, INC.. The authorized representative in Taiwan is AMESDATA BIOTECH CO., LTD..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
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