PMDA device listing

ハンドル付トレパンブレード

PMDA Medical device listing · 13B2X00074000026 · Class I

Key facts

PMDA document key 270087_13B2X00074000026_1_01
Brand names ハンドル付トレパンブレード
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 13B2X00074000026
JMDN codes 14148001
Category code A3400
Marketing authorization holder 製造販売/国際交易株式会社
Package insert date Aug 2, 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)