PMDA device listing

眼科用キャリパー

PMDA Medical device listing · 12B3X10008000006 · Class I

Key facts

PMDA document key 342007_12B3X10008000006_1_01
Brand names 眼科用キャリパー
General names (JMDN) 眼科用ナイフ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 12B3X10008000006
JMDN codes 32764001
Category code A3400
Marketing authorization holder 製造販売/シンメディコ株式会社
Package insert date Jul 1, 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)