PMDA device listing

ロータノード UX−51H−42

PMDA Medical device listing · 22000BZX00691000 · Class II

Key facts

PMDA document key 480848_22000BZX00691000_A_03
Brand names ロータノード UX−51H−42
General names (JMDN) X線管装置
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 22000BZX00691000
JMDN codes 35618000
Category code A0900
Marketing authorization holder 製造販売/東芝電子管デバイス株式会社
Package insert date Apr 21, 2009
Latest revision 2009-01
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)