PMDA device listing

フレックスカートリッジ N-アセチルプロカインアミド NAPA(DF111)

PMDA In vitro diagnostic listing · 21700AMY00033000 · Class II

Key facts

PMDA document key 341508_21700AMY00033000_B_01
Brand names フレックスカートリッジ N-アセチルプロカインアミド NAPA(DF111)
General names (JMDN) N-アセチルプロカインアミドキット
Product type In vitro diagnostic
Device class (Japan) Class II
Approval, certification or notification number 21700AMY00033000
JMDN codes 30391000
Category code A0100
Marketing authorization holder 製造販売/シーメンスヘルスケア・ダイアグノスティクス株式会社
Package insert date Jun 2, 2014
Latest revision 2013-04
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)