PMDA device listing

セレクトラ アクセサリキット

PMDA Medical device listing · 22400BZX00277000 · Class IV

Key facts

PMDA document key 650387_22400BZX00277000_A_01
Brand names セレクトラ アクセサリキット
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 22400BZX00277000
JMDN codes 35094114
Category code A5100
Marketing authorization holder 製造販売/バイオトロニックジャパン株式会社
Package insert date Dec 2, 2024
Latest revision 2024-11
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 10–99 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)