PMDA device listing

ペリカーディオセンテシスキット

PMDA Medical device listing · 21400BZY00481000 · Class II

Key facts

PMDA document key 784912_21400BZY00481000_A_02
Brand names ペリカーディオセンテシスキット
General names (JMDN) 心膜排液用カテーテル
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 21400BZY00481000
JMDN codes 10741102
Category code A5100
Marketing authorization holder 製造販売/メリットメディカル・ジャパン株式会社
Package insert date Jan 10, 2018
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)