PMDA device listing

外装ウェッジフィルター

PMDA Medical device listing · 13B1X10082000012 · Class I

Key facts

PMDA document key 784339_13B1X10082000012_0_00
Brand names 外装ウェッジフィルター
General names (JMDN) 加速装置向けコリメータ用エレクトロンアプリケータ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X10082000012
JMDN codes 42268000
Category code A0900
Marketing authorization holder 製造販売/メディカル・エキスパート株式会社
Package insert date Jun 9, 2022
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
  • No 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)