PMDA device listing

瞳孔計付き2色切替スリム回転式スイッチペンライト

PMDA Medical device listing · 27B2X00389000011 · Class I

Key facts

PMDA document key 290944_27B2X00389000011_A_01
Brand names 瞳孔計付き2色切替スリム回転式スイッチペンライト
General names (JMDN) 瞳孔計
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 27B2X00389000011
JMDN codes 13236000
Category code A2200
Marketing authorization holder 製造販売/株式会社コンテック
Package insert date Oct 1, 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)