PMDA device listing

MIS-IIフラスコ

PMDA Medical device listing · 28B2X10028000004 · Class I

Key facts

PMDA document key 471005_28B2X10028000004_A_01
Brand names MIS-IIフラスコ
General names (JMDN) 歯科用フラスコ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 28B2X10028000004
JMDN codes 42343000
Category code A6900
Marketing authorization holder 製造販売/有限会社ディーシーエルタニモト
Package insert date Jul 1, 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)