PMDA device listing

オペレーザー05

PMDA Medical device listing · 20800BZZ00081000 · Class III

Key facts

PMDA document key 830037_20800BZZ00081000_C_08
Brand names オペレーザー05
General names (JMDN) 炭酸ガスレーザ
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 20800BZZ00081000
JMDN codes 35939000
Category code A3100
Marketing authorization holder 製造販売/株式会社 吉田製作所
Package insert date Feb 24, 2010
Latest revision 2006-04
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)