PMDA device listing

ネオデント 技工用インプレッション

PMDA Medical device listing · 13B1X10163000338 · Class I

Key facts

PMDA document key 430529_13B1X10163000338_A_01
Brand names ネオデント 技工用インプレッション
General names (JMDN) 歯科印象採得用器材
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X10163000338
JMDN codes 70887000
Category code C0600
Marketing authorization holder 製造販売/ストローマン・ジャパン株式会社
Package insert date Oct 28, 2024
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
  • Yes 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)