PMDA device listing

トランセンド マイクロガイドワイヤー(トランセンド010 ガイドワイヤー)(トランセンド010 ガイドワイヤー)

PMDA Medical device listing · 22500BZX00166000 · Class IV

Key facts

PMDA document key 730093_22500BZX00166000_A_IL
Brand names トランセンド マイクロガイドワイヤー(トランセンド010 ガイドワイヤー)(トランセンド010 ガイドワイヤー)
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 22500BZX00166000
JMDN codes 35094114
Category code A5100
Marketing authorization holder 製造販売/日本ストライカー株式会社
Package insert date Mar 2, 2018
Latest revision 2018-02
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)