PMDA device listing

補聴器HB-W1AD

PMDA Medical device listing · 230AABZX00056A04 · Class II

Key facts

PMDA document key 850003_230AABZX00056A04_A_01
Brand names 補聴器HB-W1AD
General names (JMDN) デジタル式補聴器
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 230AABZX00056A04
JMDN codes 41207000
Category code A7300
Marketing authorization holder 製造販売/リオン株式会社
Package insert date Feb 10, 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)