PMDA device listing

視線分析型視野計ゲイズアナライジングペリメーターGAP

PMDA Medical device listing · 38B2X10003000002 · Class I

Key facts

PMDA document key 671791_38B2X10003000002_A_02
Brand names 視線分析型視野計ゲイズアナライジングペリメーターGAP
General names (JMDN) 自動視野計
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 38B2X10003000002
JMDN codes 16918001
Category code A2204
Marketing authorization holder 製造販売/株式会社ファインデックス
Package insert date Oct 19, 2023
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
  • Yes 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)