PMDA device listing

KeyTray レジン

PMDA Medical device listing · 23B3X10013000026 · Class I

Key facts

PMDA document key 471277_23B3X10013000026_1_01
Brand names KeyTray レジン
General names (JMDN) 歯科印象トレー用レジン
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 23B3X10013000026
JMDN codes 70832000
Category code C0300
Marketing authorization holder 製造販売/株式会社データ・デザイン
Package insert date Aug 15, 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)