PMDA device listing

OSTEOPAL plus骨セメント

PMDA Medical device listing · 30800BZX00056000 · Class III

Key facts

PMDA document key 880023_30800BZX00056000_A_01
Brand names OSTEOPAL plus骨セメント
General names (JMDN) 整形外科用骨セメント
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 30800BZX00056000
JMDN codes 35217000
Category code B0400
Marketing authorization holder 製造販売/株式会社ロバート・リード商会
Package insert date Apr 8, 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
  • 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:

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