PMDA device listing

シンプルリトラクター

PMDA Medical device listing · 09B1X10006000001 · Class I

Key facts

PMDA document key 790308_09B1X10006000001_A_01
Brand names シンプルリトラクター
General names (JMDN) 歯列矯正用ヘッドギア
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 09B1X10006000001
JMDN codes 31757000
Category code A5805
Marketing authorization holder 製造販売/株式会社モリタデンタルプロダクツ
Package insert date May 21, 2023
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)