PMDA device listing

ACM セメントミキシングボウル

PMDA Medical device listing · 13B1X10209001029 · Class I

Key facts

PMDA document key 730093_13B1X10209001029_A_01
Brand names ACM セメントミキシングボウル
General names (JMDN) 整形外科用骨セメント混合器
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X10209001029
JMDN codes 33191000
Category code A5800
Marketing authorization holder 製造販売/日本ストライカー株式会社
Package insert date Sep 1, 2026
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)