PMDA device listing

ソフラトラポン

PMDA Medical device listing · 38B3X10001000006 · Class I

Key facts

PMDA document key 730131_38B3X10001000006_A_01
Brand names ソフラトラポン
General names (JMDN) 医療脱脂綿
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 38B3X10001000006
JMDN codes 70975000
Category code B0400
Marketing authorization holder 製造販売/丸三産業株式会社
Package insert date Jan 15, 2016
Latest revision 2015-12
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)