PMDA device listing

ドクターフォネット ライト No.185

PMDA Medical device listing · 11B2X00021185001 · Class I

Key facts

PMDA document key 260059_11B2X00021185001_A_01
Brand names ドクターフォネット ライト No.185
General names (JMDN) 機械式聴診器
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 11B2X00021185001
JMDN codes 13755000
Category code A1300
Marketing authorization holder 製造販売/ケンツメディコ株式会社
Package insert date Jul 7, 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
  • 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)