PMDA device listing

HiQ+バイポーラ Aコード(A60001C バイポーラコード(ERBE用、2ピンタイプ))

PMDA Medical device listing · 13B1X00277000698 · Class I

Key facts

PMDA document key 180590_13B1X00277000698_B_01
Brand names HiQ+バイポーラ Aコード(A60001C バイポーラコード(ERBE用、2ピンタイプ))
General names (JMDN) 再使用可能な高周波処置用内視鏡能動器具
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00277000698
JMDN codes 70164010
Category code A2900
Marketing authorization holder 製造販売/オリンパスメディカルシステムズ株式会社
Package insert date Aug 4, 2025
Latest revision 2025-07
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)