PMDA device listing

ペンタックス ビデオ大腸スコープ EC34-i10シリーズ

PMDA Medical device listing · 222AGBZX00244000 · Class II

Key facts

PMDA document key 701814_222AGBZX00244000_A_02
Brand names ペンタックス ビデオ大腸スコープ EC34-i10シリーズ
General names (JMDN) ビデオ軟性大腸鏡
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 222AGBZX00244000
JMDN codes 36117000
Category code A2500
Marketing authorization holder 製造販売/PENTAX Medical合同会社
Package insert date Aug 4, 2026
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)