PMDA device listing

補聴器HI-A2H

PMDA Medical device listing · 220AABZX00119000 · Class II

Key facts

PMDA document key 850003_220AABZX00119000_A_01
Brand names 補聴器HI-A2H
General names (JMDN) カナル型補聴器
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 220AABZX00119000
JMDN codes 41209000
Category code A7300
Marketing authorization holder 製造販売/リオン株式会社
Package insert date Nov 21, 2014
Latest revision 2012-11
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)