PMDA device listing

腋下用リユーザブル体温プローブ TypeV

PMDA Medical device listing · 13B1X00003M10002 · Class I

Key facts

PMDA document key 670053_13B1X00003M10002_A_01
Brand names 腋下用リユーザブル体温プローブ TypeV
General names (JMDN) 再使用可能な体温計プローブ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00003M10002
JMDN codes 37340001
Category code A2100
Marketing authorization holder 製造販売/フクダ電子株式会社
Package insert date Aug 3, 2018
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
  • Yes 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)