PMDA device listing

メディコム不織布ガーゼ

PMDA Medical device listing · 28B3X00001000011 · Class I

Key facts

PMDA document key 170551_28B3X00001000011_W_07
Brand names メディコム不織布ガーゼ
General names (JMDN) 医療用不織布
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 28B3X00001000011
JMDN codes 34655000
Category code B0400
Marketing authorization holder 製造販売/A.R.メディコム・インク・アジア・リミテッド
Package insert date Nov 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)