Taiwan FDA registration 91a7354e19bc8d23e026c79733064d11
DIGIVAL (Non-sterile)
TW: 立即發分析儀 (未滅菌)
Taiwan·Risk Class 1·MD·Abbott Diagnostics Scarborough, Inc.·Registered Aug 21, 2018 – Aug 21, 2028ActiveRegistration details
- Analysis ID
- 91a7354e19bc8d23e026c79733064d11
- License Form
- Ministry of Health Medical Device Import No. 019519
- Customs Code
- DHA09401951900
Company information
- Manufacturer
- Abbott Diagnostics Scarborough, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- Limited to the first level of identification range of "density meter/scanner for clinical use (integration, reflection, thin layer or radioactive color layer analysis)" (A.2400) under the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A2400 Density Meter/Scanner for Clinical Use (Integrated, Reflective, Thin-Layer or Radiochromatography)
- Import Information
- Imported from abroad; GMP
Dates and status
- Registration Date
- Aug 21, 2018
- Expiry Date
- Aug 21, 2028
About this record
Access comprehensive regulatory information for DIGIVAL (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 91a7354e19bc8d23e026c79733064d11 and manufactured by Abbott Diagnostics Scarborough, Inc.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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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