PMDA device listing

カルテット Ex ファミリー Nの付属品(スタイレット)

PMDA Medical device listing · 22800BZX00376A01 · Class IV

Key facts

PMDA document key 381005_22800BZX00376A01_D_01
Brand names カルテット Ex ファミリー Nの付属品(スタイレット)
General names (JMDN) 植込み型除細動器・ペースメーカリード
Product type Medical device
Device class (Japan) Class IV
Approval, certification or notification number 22800BZX00376A01
JMDN codes 36241000
Category code A0700
Marketing authorization holder 製造販売/アボットメディカルジャパン合同会社
Package insert date May 21, 2026
Latest revision 2026-04
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
  • 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)