PMDA device listing

間欠式バルーンカテーテル

PMDA Medical device listing · 20700BZZ01034000 · Class II

Key facts

PMDA document key 460051_20700BZZ01034000_F_01
Brand names 間欠式バルーンカテーテル
General names (JMDN) 間欠泌尿器用カテーテル
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 20700BZZ01034000
JMDN codes 36125000
Category code A5100
Marketing authorization holder 製造販売/株式会社 塚田メディカル・リサーチ
Package insert date May 9, 2024
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 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)