PMDA device listing

ICP エクスプレス

PMDA Medical device listing · 20800BZY00959000 · Class III

Key facts

PMDA document key 150924_20800BZY00959000_B_05
Brand names ICP エクスプレス
General names (JMDN) 頭蓋内圧力計
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 20800BZY00959000
JMDN codes 35249000
Category code A2100
Marketing authorization holder 製造販売/Integra Japan 株式会社
Package insert date Feb 2, 2026
Latest revision 2020-11
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)