Taiwan FDA registration f40ae5b565f884070963998839abbc7d

“EUROIMMUN” Anti-M2-3E ELISA (IgG)

TW: “歐蒙” 免疫酵素法抗粒線體M2 IgG抗體試劑

Taiwan·Risk Class 2·MD·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered May 22, 2018 – May 22, 2028Active

Registration details

Analysis ID: f40ae5b565f884070963998839abbc7d
License Form: Ministry of Health Medical Device Import No. 031115
Customs Code: DHA05603111506

Company information

Manufacturer: EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
Manufacturer Country: Germany
Authorized Representative: EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE)

Product details

Intended Use: This product is used for in vitro qualitative or semi-quantitative detection of anti-granular M2 IgG antibodies in human serum or plasma to assist in the diagnosis of primary biliary cirrhosis (PBC).
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C5090 Anti-granular antibody immunoassay system
Import Information: Imported from abroad

Dates and status

Registration Date: May 22, 2018
Expiry Date: May 22, 2028

About this record

Access comprehensive regulatory information for “EUROIMMUN” Anti-M2-3E ELISA (IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f40ae5b565f884070963998839abbc7d and manufactured by EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG. The authorized representative in Taiwan is EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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