PMDA device listing

一般X線撮影装置 MRAD−A25S形 RADREX

PMDA Medical device listing · 218ABBZX00007000 · Class II

Key facts

PMDA document key 480123_218ABBZX00007000_A_07
Brand names 一般X線撮影装置 MRAD−A25S形 RADREX
General names (JMDN) 据置型アナログ式汎用X線診断装置
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 218ABBZX00007000
JMDN codes 37644010
Category code A0900
Marketing authorization holder 製造販売/東芝メディカル製造株式会社
Package insert date Nov 10, 2011
Latest revision 2011-08
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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