PMDA device listing

眼科手術用付属品(灌流ハンドピース(短))

PMDA Medical device listing · 22100BZX01025000 · Class III

Key facts

PMDA document key 530150_22100BZX01025000_K_01
Brand names 眼科手術用付属品(灌流ハンドピース(短))
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 22100BZX01025000
JMDN codes 70652000
Category code A1200
Marketing authorization holder 製造販売/株式会社ニデック
Package insert date Mar 24, 2023
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)