PMDA device listing

Speed Dental プライヤー

PMDA Medical device listing · 40B1X10004000006 · Class I

Key facts

PMDA document key 202039_40B1X10004000006_A_01
Brand names Speed Dental プライヤー
General names (JMDN) 歯科矯正用プライヤ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 40B1X10004000006
JMDN codes 33209000
Category code A3900
Marketing authorization holder 製造販売/株式会社岡部
Package insert date Jun 29, 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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