PMDA device listing

ホルダーボックス

PMDA Medical device listing · 04B3X00001000023 · Class I

Key facts

PMDA document key 710019_04B3X00001000023_1_01
Brand names ホルダーボックス
General names (JMDN) 胸部画像診断・放射線治療用患者体位固定具
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 04B3X00001000023
JMDN codes 40899000
Category code A0900
Marketing authorization holder 製造販売/北斗精機株式会社
Package insert date Jan 27, 2021
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)