PMDA device listing

セメックスRX

PMDA Medical device listing · 20200BZY00777000 · Class III

Key facts

PMDA document key 300076_20200BZY00777000_A_01
Brand names セメックスRX
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 20200BZY00777000
JMDN codes 35217000
Category code B0400
Marketing authorization holder 製造販売/株式会社TKB
Package insert date Sep 24, 2026
Latest revision 2022-07
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:

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