Taiwan FDA registration 707b85e4fdc2848e5987df4eeb887429

"Arkra" ammonia analyzer (unsterilized)

TW: "愛科來" 氨測定儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Arkray Factory Inc., Head office factory·Registered Jan 06, 2016 – Jan 06, 2026Expired
Registration details
Analysis ID
707b85e4fdc2848e5987df4eeb887429
Customs Code
DHA09401605202
Company information
Manufacturer Country
Japan
Authorized Representative
SYNGEN BIOTECH CO., LTD.
Product details
Intended Use
It is limited to the first-level identification scope of the "Blood Ammonia Test System (A.1065)" of the Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1065 血氨試驗系統
Import Information
Input;; QMS/QSD
Dates and status
Registration Date
Jan 06, 2016
Expiry Date
Jan 06, 2026
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About this record

Access comprehensive regulatory information for "Arkra" ammonia analyzer (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 707b85e4fdc2848e5987df4eeb887429 and manufactured by Arkray Factory Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Arkray Factory Inc., Head office factory, and 1 recent registrations in the same category. 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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