PMDA device listing

無散瞳眼底カメラ TRC-NW8の付属品 外部固視標

PMDA Medical device listing · 220AABZX00003000 · Class II

Key facts

PMDA document key 480068_220AABZX00003000_B_01
Brand names 無散瞳眼底カメラ TRC-NW8の付属品 外部固視標
General names (JMDN) 眼底カメラ
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 220AABZX00003000
JMDN codes 10551000
Category code A2200
Marketing authorization holder 製造販売/株式会社トプコン
Package insert date Mar 8, 2022
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)