PMDA device listing

空圧頭蓋骨穿孔器用ドリル

PMDA Medical device listing · 13B1X00306G00670 · Class I

Key facts

PMDA document key 750054_13B1X00306G00670_A_01
Brand names 空圧頭蓋骨穿孔器用ドリル
General names (JMDN) 頭蓋骨用バー
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00306G00670
JMDN codes 10520001
Category code A4900
Marketing authorization holder 製造販売/ミズホ株式会社
Package insert date Dec 27, 2017
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)