PMDA device listing

GPPヒートリムーバー

PMDA Medical device listing · 21B2X10010000003 · Class I

Key facts

PMDA document key 370999_21B2X10010000003_3_01
Brand names GPPヒートリムーバー
General names (JMDN) 歯科用練成充填形成器
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 21B2X10010000003
JMDN codes 41861000
Category code A6500
Marketing authorization holder 製造販売/有限会社角野製作所
Package insert date Sep 19, 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)