PMDA device listing

多機能未就学児用パッド1

PMDA Medical device listing · 13B1X10153000005 · Class I

Key facts

PMDA document key 580844_13B1X10153000005_A_03
Brand names 多機能未就学児用パッド1
General names (JMDN) 体表用除細動電極
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X10153000005
JMDN codes 15033001
Category code A1200
Marketing authorization holder 製造販売/株式会社CU
Package insert date Apr 26, 2024
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)