PMDA device listing

ネックスコンプ

PMDA Medical device listing · 229AKBZI00018000 · Class II

Key facts

PMDA document key 342274_229AKBZI00018000_A_01
Brand names ネックスコンプ
General names (JMDN) 歯科充填用コンポジットレジン
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 229AKBZI00018000
JMDN codes 70847002
Category code C0500
Marketing authorization holder 製造販売/株式会社ジオメディ
Package insert date Mar 1, 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)