PMDA device listing

MONNALベンチレータ(MONNALT50ベンチレータ)

PMDA Medical device listing · 22400BZX00293000 · Class III

Key facts

PMDA document key 100001_22400BZX00293000_A_01
Brand names MONNALベンチレータ(MONNALT50ベンチレータ)
General names (JMDN) 成人用人工呼吸器
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 22400BZX00293000
JMDN codes 42411000
Category code A0600
Marketing authorization holder 製造販売/アイ・エム・アイ株式会社
Package insert date Mar 28, 2024
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 10–99 Package insert revisions
  • 1–9 Related PMDA documents
  • Listed Listed on the PMDA site
  • Yes 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:

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