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"Orgentec" Anti-EBV (ZEBRA) IgM (non-sterile) - Taiwan Registration 3edfb12d4cc64ddc03e5640b0e2258e8

Access comprehensive regulatory information for "Orgentec" Anti-EBV (ZEBRA) IgM (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 3edfb12d4cc64ddc03e5640b0e2258e8 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The authorized representative in Taiwan is IN FUNG CO., LTD..

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3edfb12d4cc64ddc03e5640b0e2258e8
Registration Details
Taiwan FDA Registration: 3edfb12d4cc64ddc03e5640b0e2258e8
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Device Details

"Orgentec" Anti-EBV (ZEBRA) IgM (non-sterile)
TW: "ๆญๆท" EB็—…ๆฏ’(ZEBRA) IgMๆŠ—้ซ”่ฉฆๅŠ‘ (ๆœชๆป…่Œ)
Risk Class 1
MD

Registration Details

3edfb12d4cc64ddc03e5640b0e2258e8

Ministry of Health Medical Device Import No. 015445

DHA09401544503

Company Information

Germany

Product Details

Limited to the first level identification range of "Epstein-Barr virus serum reagent (C.3235)" of the Measures for the Administration of Medical Devices.

C Immunology and microbiology devices

C3235 Epstein-Barr virus serum reagent

Imported from abroad

Dates and Status

Jul 08, 2015

Jul 08, 2025