PMDA device listing

フルトンATE回転把持鉗子鰐口型

PMDA Medical device listing · 13B2X10217000005 · Class I

Key facts

PMDA document key 261899_13B2X10217000005_A_01
Brand names フルトンATE回転把持鉗子鰐口型
General names (JMDN) 内視鏡用軟性把持鉗子
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B2X10217000005
JMDN codes 35524000
Category code A2500
Marketing authorization holder 製造販売/日本アッシュ株式会社
Package insert date Jul 28, 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
  • 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)