PMDA device listing

ナイトグラフ成人用電極

PMDA Medical device listing · 14B3X10044000002 · Class I

Key facts

PMDA document key 471890_14B3X10044000002_A_01
Brand names ナイトグラフ成人用電極
General names (JMDN) 頭皮脳波用電極
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 14B3X10044000002
JMDN codes 11440001, 35036000, 11441001
Category code A2100
Marketing authorization holder 製造販売/帝国通信工業株式会社〒211-8530 神奈川県川崎市中原区苅宿45-1
Package insert date Dec 19, 2025
Latest revision 2025-12
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)