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Safidesilicone balloon catheterwith temperature sensor - PMDA ID 470034_16200BZZ02012000_A_01_05

サフィードシリコーンバルーンカテーテル温度センサー付

Access comprehensive regulatory information for Safidesilicone balloon catheterwith temperature sensor (サフィードシリコーンバルーンカテーテル温度センサー付) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 470034_16200BZZ02012000_A_01_05 and manufactured by Terumo Corporation. The device information was last updated on March 22, 2022.

This page provides complete registration details including device class (A2100), classification (Body Orifice Single Use Thermometer Probe / 人体開口部単回使用体温計プローブ), 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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PMDA Official Data
Bilingual (EN/JP)
MD
A2100
470034_16200BZZ02012000_A_01_05
MD
A2100
Safidesilicone balloon catheterwith temperature sensor
サフィードシリコーンバルーンカテーテル温度センサー付
PMDA ID: 470034_16200BZZ02012000_A_01_05
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Intended Use / 使用目的
English

This product can be used for long-term urination or urinary bleeding hemostasis, and can measure the intravesical temperature.

日本語 (Japanese)

本品は長期導尿あるいは尿路出血止血等に使用する他、膀胱内温度を測定することができる。

Device Classification / 分類
Device Type
MD
Device Class
A2100
Class Name (English)
Body Orifice Single Use Thermometer Probe
Class Name (日本語)
人体開口部単回使用体温計プローブ
Registration Information / 登録情報
PMDA ID
470034_16200BZZ02012000_A_01_05
Last Update Date
March 22, 2022
Official Documents
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/テルモ株式会社
Product Names / 製品名
Market Name (English)
Safidesilicone balloon catheterwith temperature sensor
Market Name (日本語)
サフィードシリコーンバルーンカテーテル温度センサー付