PMDA device listing

フォームチップアプリケーター

PMDA Medical device listing · 13B1X10093170001 · Class I

Key facts

PMDA document key 111882_13B1X10093170001_A_32
Brand names フォームチップアプリケーター
General names (JMDN) 医科用捲綿子
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X10093170001
JMDN codes 10172000
Category code A5400
Marketing authorization holder 製造販売/Arthrex Japan合同会社
Package insert date Jul 5, 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
  • 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)