PMDA device listing

ペリフェラルガイドワイヤー3

PMDA Medical device listing · 23000BZX00198000 · Class IV

Key facts

PMDA document key 100407_23000BZX00198000_A_01
Brand names ペリフェラルガイドワイヤー3
General names (JMDN) 心臓・中心循環系用カテーテルガイドワイヤ
Product type Medical device
Device class (Japan) Class IV
Approval, certification or notification number 23000BZX00198000
JMDN codes 35094114
Category code A5100
Marketing authorization holder 製造販売/朝日インテック株式会社
Package insert date Sep 30, 2019
Latest revision 2019-04
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)