PMDA device listing

ソニックワイヤーソー

PMDA Medical device listing · 28B1X10021000118 · Class I

Key facts

PMDA document key 230432_28B1X10021000118_A_01
Brand names ソニックワイヤーソー
General names (JMDN) 手術用のこぎり
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 28B1X10021000118
JMDN codes 13448001
Category code A4000
Marketing authorization holder 製造販売/株式会社 木下技研
Package insert date May 20, 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)