Japan PMDA registration 700025_13A2X00206000109_V_02_04

Ecclusis Reagent TSH (Cobus System)

JP: エクルーシス試薬 TSH(コバス システム)
Japan flagJapan·IVD·IVD·Updated February 14, 2025
Device classification / 分類
Device Type
IVD
Device Class
IVD
Class Name (English)
Thyroid stimulating hormone kit
Class Name (日本語)
甲状腺刺激ホルモンキット
Registration information / 登録情報
PMDA ID
700025_13A2X00206000109_V_02_04
Last Update Date
February 14, 2025
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/ロシュ・ダイアグノスティックス株式会社
About this record

Access comprehensive regulatory information for Ecclusis Reagent TSH (Cobus System) (エクルーシス試薬 TSH(コバス システム)) in the Japan medical device market through Pure Global AI's free bilingual database. This IVD medical device is registered under PMDA ID 700025_13A2X00206000109_V_02_04 and manufactured by Roche Diagnostics K.K.. The device information was last updated on February 14, 2025.

This page provides complete registration details including device class (IVD), classification (Thyroid stimulating hormone kit / 甲状腺刺激ホルモンキット), manufacturer information (English and Japanese), and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.

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