PMDA device listing

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PMDA Medical device listing · 28B3X10030BA4629 · Class I

Key facts

PMDA document key 100812_28B3X10030BA4629_A_01
Brand names 抜去ドライバー
General names (JMDN) 脊椎手術用器械
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 28B3X10030BA4629
JMDN codes 70963001
Category code A5800
Marketing authorization holder 製造販売/アリオメディカル株式会社
Package insert date Jun 29, 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)