Taiwan FDA registration 9530575bb51db94ed7ee44895bae4f68
"HealthYou" RealStar EBV PCR Kit (Non-Sterile)
TW: "信義興" EB病毒核酸檢驗試劑組 (未滅菌)
Taiwan·Risk Class 1·MD·ALTONA DIAGNOSTICS GMBH·Registered Dec 17, 2014 – Dec 17, 2024ExpiredRegistration details
- Analysis ID
- 9530575bb51db94ed7ee44895bae4f68
- License Form
- Ministry of Health Medical Device Import No. 014761
- Customs Code
- DHA09401476108
Company information
- Manufacturer
- ALTONA DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- HEALTHYOU CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of "Epstein-Barr virus serum reagent (C.3235)" of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3235 Epstein-Barr virus serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 17, 2014
- Expiry Date
- Dec 17, 2024
About this record
Access comprehensive regulatory information for "HealthYou" RealStar EBV PCR Kit (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 9530575bb51db94ed7ee44895bae4f68 and manufactured by ALTONA DIAGNOSTICS GMBH. The authorized representative in Taiwan is HEALTHYOU CO., LTD..
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