PMDA device listing

プロフィーカップ(医療機器届出番号 13B2X10359020003)

PMDA Medical device listing · 13B2X10359020003 · Class I

Key facts

PMDA document key 790122_13B2X10359020003_A_01
Brand names プロフィーカップ(医療機器届出番号 13B2X10359020003)
General names (JMDN) 歯磨カップ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B2X10359020003
JMDN codes 16184000
Category code C0900
Marketing authorization holder 製造販売/株式会社モリムラ
Package insert date Oct 31, 2022
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:

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