PMDA device listing

樋口式産科聴診器

PMDA Medical device listing · 11B1X00002Z13003 · Class I

Key facts

PMDA document key 100144_11B1X00002Z13003_0_38
Brand names 樋口式産科聴診器
General names (JMDN) 胎児用聴診器
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 11B1X00002Z13003
JMDN codes 32659000
Category code A1301
Marketing authorization holder 製造販売/アトムメディカル株式会社
Package insert date Jan 17, 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
  • 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)