PMDA device listing

角膜トレパン

PMDA Medical device listing · 13B1X00049KP2400 · Class I

Key facts

PMDA document key 340375_13B1X00049KP2400_A_01
Brand names 角膜トレパン
General names (JMDN) 手動式角膜トレパン
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00049KP2400
JMDN codes 14148001
Category code A3400
Marketing authorization holder 製造販売/ジャパンフォーカス株式会社
Package insert date Sep 10, 2021
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)