PMDA device listing

CRフォーマー

PMDA Medical device listing · 09B2X00010000021 · Class I

Key facts

PMDA document key 340017_09B2X00010000021_A_01
Brand names CRフォーマー
General names (JMDN) 歯科用充填器
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 09B2X00010000021
JMDN codes 70680000
Category code A6501
Marketing authorization holder 製造販売/株式会社シオダ
Package insert date May 7, 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
  • 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)