Japan PMDA registration 530366_23000BZX00330000_A_01_02

Cortiva custom pack

JP: Cortiva カスタムパック
Japan flagJapan·MD·A0700·Updated October 20, 2022
Intended use / 使用目的
English
This product is intended to be used as an extracorporeal circulation circuit during open heart surgery or cardiopulmonary support. Many of the components of this product have a heparin coating on the blood-contact surface.
日本語 (Japanese)
本品は、開心手術又は心肺補助の際に体外循環用回路として使用することを目的とする。本品の構成品の多くは、血液接触面にヘパリンコーティングが施されている。
Device classification / 分類
Device Type
MD
Device Class
A0700
Class Name (English)
Cardiopulmonary bypass circuit system using heparin
Class Name (日本語)
ヘパリン使用人工心肺用回路システム
Registration information / 登録情報
PMDA ID
530366_23000BZX00330000_A_01_02
Last Update Date
October 20, 2022
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/日本メドトロニック株式会社
About this record

Access comprehensive regulatory information for Cortiva custom pack (Cortiva カスタムパック) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 530366_23000BZX00330000_A_01_02 and manufactured by Medtronic Japan Co., Ltd.. The device information was last updated on October 20, 2022.

This page provides complete registration details including device class (A0700), classification (Cardiopulmonary bypass circuit system using heparin / ヘパリン使用人工心肺用回路システム), 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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