PMDA device listing

シラスコン排液バッグ

PMDA Medical device listing · 09B1X00004000112 · Class I

Key facts

PMDA document key 130061_09B1X00004000112_A_02
Brand names シラスコン排液バッグ
General names (JMDN) 排液バック
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 09B1X00004000112
JMDN codes 70308000
Category code A5100
Marketing authorization holder 製造販売/フォルテ グロウ メディカル株式会社
Package insert date May 10, 2021
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)