PMDA device listing

ステルスステーション ナビゲーションシステム

PMDA Medical device listing · 22600BZX00110000 · Class III

Key facts

PMDA document key 530366_22600BZX00110000_B_01
Brand names ステルスステーション ナビゲーションシステム
General names (JMDN) 脳神経外科手術用ナビゲーションユニット
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 22600BZX00110000
JMDN codes 38723023
Category code A1200
Marketing authorization holder 製造販売/日本メドトロニック株式会社
Package insert date Nov 19, 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
  • Yes 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)