PMDA device listing

AWLポイント

PMDA Medical device listing · 21B1X10001000042 · Class I

Key facts

PMDA document key 170436_21B1X10001000042_A_01
Brand names AWLポイント
General names (JMDN) 歯科技工用アブレシブ研削器具
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 21B1X10001000042
JMDN codes 70901000
Category code C0900
Marketing authorization holder 製造販売/株式会社エスイーエム
Package insert date Jul 15, 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)