PMDA device listing

IMサンプラー

PMDA Medical device listing · 12B3X10023000005 · Class I

Key facts

PMDA document key 370792_12B3X10023000005_1_01
Brand names IMサンプラー
General names (JMDN) 婦人科用剥離子
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 12B3X10023000005
JMDN codes 70955000
Category code A4200
Marketing authorization holder 製造販売/ステインケミカル株式会社
Package insert date Jul 29, 2021
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)