PMDA device listing

GALWAY大動脈パンチ

PMDA Medical device listing · 13B1X00319CS0004 · Class I

Key facts

PMDA document key 630200_13B1X00319CS0004_A_01
Brand names GALWAY大動脈パンチ
General names (JMDN) 再使用可能な手術用パンチ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00319CS0004
JMDN codes 35285001
Category code A3000
Marketing authorization holder 製造販売/株式会社バイタル
Package insert date Jul 11, 2024
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)