PMDA device listing

ホワイトスターシグネチャーの付属品

PMDA Medical device listing · 22100BZX00564000 · Class III

Key facts

PMDA document key 630215_22100BZX00564000_D_01
Brand names ホワイトスターシグネチャーの付属品
General names (JMDN) 白内障・硝子体手術装置
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 22100BZX00564000
JMDN codes 70652000
Category code A1200
Marketing authorization holder 製造販売/エイエムオー・ジャパン株式会社
Package insert date May 19, 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)