PMDA device listing

23R-000054杉原式剥離スパーテル

PMDA Medical device listing · 13B1X00048002505 · Class I

Key facts

PMDA document key 130152_13B1X00048002505_1_01
Brand names 23R-000054杉原式剥離スパーテル
General names (JMDN) 眼科手術用スパーテル
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00048002505
JMDN codes 32754001
Category code A4200
Marketing authorization holder 製造販売/株式会社イナミ
Package insert date Sep 30, 2025
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)