Taiwan FDA registration f8f016261e77844cb31c15eac5135ad5

"Omon immunofluorescence" anti-epidermal spinous cell desmosomes antibody/anti-epidermal basement membrane antibody reagent

TW: “歐蒙”免疫螢光法抗表皮棘細胞橋粒抗體/抗表皮基底膜抗體試劑
Taiwan flagTaiwan·Risk Class 2·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered May 06, 2019 – May 06, 2029Active
Registration details
Analysis ID
f8f016261e77844cb31c15eac5135ad5
Customs Code
DHA05603242105
Company information
Manufacturer Country
Germany
Product details
Intended Use
This product is used for the in vitro qualitative or semi-quantitative detection of anti-spinous desmosomes and epidermal basement membrane antibody immunoglobulin G (IgG) in patient samples to assist in the diagnosis of autoimmune bullous skin diseases.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.5660 多發性自體抗體免疫試驗系統
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
May 06, 2019
Expiry Date
May 06, 2029
About this record

Access comprehensive regulatory information for "Omon immunofluorescence" anti-epidermal spinous cell desmosomes antibody/anti-epidermal basement membrane antibody reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f8f016261e77844cb31c15eac5135ad5 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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