Japan PMDA registration 341508_13E1X80031000046_A_01_02

Atelica CH Phenytoin (Phny)

JP: アテリカCH フェニトイン(Phny)
Japan flagJapan·IVD·IVD·Updated December 23, 2021
Intended use / 使用目的
English
Determination of phenytoin in serum or plasma
日本語 (Japanese)
血清又は血漿中のフェニトインの測定
Device classification / 分類
Device Type
IVD
Device Class
IVD
Class Name (English)
phenytoin kit
Class Name (日本語)
フェニトインキット
Registration information / 登録情報
PMDA ID
341508_13E1X80031000046_A_01_02
Last Update Date
December 23, 2021
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/シーメンスヘルスケア・ダイアグノスティクス株式会社
About this record

Access comprehensive regulatory information for Atelica CH Phenytoin (Phny) (アテリカCH フェニトイン(Phny)) in the Japan medical device market through Pure Global AI's free bilingual database. This IVD medical device is registered under PMDA ID 341508_13E1X80031000046_A_01_02 and manufactured by Manufacture and sales / Siemens Healthcare Diagnostics Co., Ltd.. The device information was last updated on December 23, 2021.

This page provides complete registration details including device class (IVD), classification (phenytoin kit / フェニトインキット), manufacturer information (English and Japanese), intended use, 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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