PMDA device listing

MORACT ブレード

PMDA Medical device listing · 15B1X10003000031 · Class I

Key facts

PMDA document key 342371_15B1X10003000031_A_01
Brand names MORACT ブレード
General names (JMDN) インパクタ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 15B1X10003000031
JMDN codes 32856000
Category code A1200
Marketing authorization holder 製造販売/JMR株式会社
Package insert date Jul 15, 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)