Taiwan FDA registration b909017ca59dc0182885c3a8086a6494

Lumipulse G Myoglobin

TW: 錄秘帕斯G肌紅蛋白檢驗試劑

Taiwan·Risk Class 2·MD·FUJIREBIO INC. SAGAMIHARA FACILITY.·Registered Jul 14, 2020 – Jul 14, 2025Expired

Registration details

Analysis ID: b909017ca59dc0182885c3a8086a6494
License Form: Ministry of Health Medical Device Import No. 033504
Customs Code: DHA05603350401

Company information

Manufacturer: FUJIREBIO INC. SAGAMIHARA FACILITY.
Manufacturer Country: Japan
Authorized Representative: Grand Marquis IVD CO., LTD.

Product details

Intended Use: This product is used with the Secret Paz G1200 Chemical Cryoluminometer to measure myoglobin in serum or plasma.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C5680 Myoglobin immunoassay system
Import Information: Imported from abroad

Dates and status

Registration Date: Jul 14, 2020
Expiry Date: Jul 14, 2025

About this record

Access comprehensive regulatory information for Lumipulse G Myoglobin in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b909017ca59dc0182885c3a8086a6494 and manufactured by FUJIREBIO INC. SAGAMIHARA FACILITY.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

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