PMDA device listing

MiraQ フロー・・イメージングシステム

PMDA Medical device listing · 304AGBZI00010000 · Class II

Key facts

PMDA document key 785285_304AGBZI00010000_A_01
Brand names MiraQ フロー・・イメージングシステム
General names (JMDN) 超音波血流計
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 304AGBZI00010000
JMDN codes 10432000, 40761000
Category code A2100
Marketing authorization holder 製造販売/Medistim Japan株式会社
Package insert date Mar 17, 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:

Browse all PMDA medical device and IVD listings (Japan)