PMDA device listing

TMSガイドピン

PMDA Medical device listing · 28B1X10009580009 · Class I

Key facts

PMDA document key 500931_28B1X10009580009_A_01
Brand names TMSガイドピン
General names (JMDN) 骨手術用器械
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 28B1X10009580009
JMDN codes 70962001
Category code A5800
Marketing authorization holder 製造販売/株式会社トータルメディカルサプライ
Package insert date May 18, 2022
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)