PMDA device listing

スーパーフィクソーブEX

PMDA Medical device listing · 23100BZX00062000 · Class III

Key facts

PMDA document key 471626_23100BZX00062000_B_02
Brand names スーパーフィクソーブEX
General names (JMDN) 吸収性体内固定用プレート
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 23100BZX00062000
JMDN codes 35241004
Category code B0400
Marketing authorization holder 製造販売/帝人メディカルテクノロジー株式会社
Package insert date Dec 3, 2020
Latest revision 2020-11
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)