PMDA device listing

Katena単回使用検査用レンズ

PMDA Medical device listing · 20B1X10006000028 · Class I

Key facts

PMDA document key 400505_20B1X10006000028_A_01
Brand names Katena単回使用検査用レンズ
General names (JMDN) 検眼レンズ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 20B1X10006000028
JMDN codes 34653000
Category code A2200
Marketing authorization holder 製造販売/株式会社タカギセイコー
Package insert date Sep 30, 2024
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)