PMDA device listing

EXトランセント

PMDA Medical device listing · 13B2X10368000005 · Class I

Key facts

PMDA document key 510637_13B2X10368000005_A_01
Brand names EXトランセント
General names (JMDN) 歯面研磨材
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B2X10368000005
JMDN codes 70904000
Category code C0900
Marketing authorization holder 製造販売/ナノオプテック有限会社
Package insert date Jul 30, 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)