PMDA device listing

オーム電子体温計MT418-Y

PMDA Medical device listing · 306AKBZX00046000 · Class II

Key facts

PMDA document key 180566_306AKBZX00046000_A_01
Brand names オーム電子体温計MT418-Y
General names (JMDN) 電子体温計
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 306AKBZX00046000
JMDN codes 14032010
Category code A1600
Marketing authorization holder 製造販売/株式会社オーム電機
Package insert date Jan 28, 2025
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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