PMDA device listing

MR イメージング装置 AIRIS Ventoの付属品 QD Flexible Body コイル(S)

PMDA Medical device listing · 221ABBZX00062000 · Class II

Key facts

PMDA document key 671001_221ABBZX00062000_Q_02
Brand names MR イメージング装置 AIRIS Ventoの付属品 QD Flexible Body コイル(S)
General names (JMDN) 永久磁石式全身用MR装置
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 221ABBZX00062000
JMDN codes 37652000
Category code A2100
Marketing authorization holder 製造販売/富士フイルム株式会社
Package insert date May 25, 2026
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
  • 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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