PMDA device listing

ネオジェン

PMDA Medical device listing · 30400BZX00094000 · Class III

Key facts

PMDA document key 630024_30400BZX00094000_A_01
Brand names ネオジェン
General names (JMDN) 非吸収性骨再生用材料
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 30400BZX00094000
JMDN codes 70437103
Category code B0400
Marketing authorization holder 製造販売/白水貿易株式会社
Package insert date Nov 8, 2022
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)