PMDA device listing

ACT ドリル エクステンション

PMDA Medical device listing · 13B1X00079000081 · Class I

Key facts

PMDA document key 630198_13B1X00079000081_A_01
Brand names ACT ドリル エクステンション
General names (JMDN) ドライバ及び抜出器
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00079000081
JMDN codes 11345000
Category code A5800
Marketing authorization holder 製造販売/ジンヴィ・ジャパン合同会社
Package insert date Dec 1, 2025
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)