PMDA device listing

リフィニティ

PMDA Medical device listing · 22800BZX00299000 · Class III, Class IV

Key facts

PMDA document key 670277_22800BZX00299000_A_02
Brand names リフィニティ
General names (JMDN) 中心循環系血管内超音波カテーテル
Product type Medical device
Device class (Japan) Class III, Class IV
Approval, certification or notification number 22800BZX00299000
JMDN codes 70289004, 70289003
Category code A5100
Marketing authorization holder 製造販売/株式会社フィリップス・ジャパン
Package insert date Aug 19, 2026
Latest revision 2023-05
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)