PMDA device listing

LICトレーナー

PMDA Medical device listing · 11B3X10044000001 · Class I

Key facts

PMDA document key 202126_11B3X10044000001_A_01
Brand names LICトレーナー
General names (JMDN) 非能動型呼吸運動訓練装置
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 11B3X10044000001
JMDN codes 11634001
Category code A5800
Marketing authorization holder 製造販売/カーターテクノロジーズ株式会社
Package insert date Jun 28, 2021
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • No Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

Browse all PMDA medical device and IVD listings (Japan)