PMDA device listing

ゲートウェイ Y-アダプター

PMDA Medical device listing · 222ABBZX00103000 · Class II

Key facts

PMDA document key 300500_222ABBZX00103000_A_01
Brand names ゲートウェイ Y-アダプター
General names (JMDN) バルーン拡張式血管形成術向けカテーテル用コネクタ
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 222ABBZX00103000
JMDN codes 36177000
Category code A5100
Marketing authorization holder 製造販売/ボストン・サイエンティフィックジャパン株式会社
Package insert date Jun 15, 2026
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 10–99 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)