PMDA device listing

保持装置 4SR-N

PMDA Medical device listing · 14B2X00057000013 · Class I

Key facts

PMDA document key 770033_14B2X00057000013_A_01
Brand names 保持装置 4SR-N
General names (JMDN) X線管支持床支持台
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 14B2X00057000013
JMDN codes 37076000
Category code A0912
Marketing authorization holder 製造販売/アールテック株式会社
Package insert date Apr 22, 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
  • Yes 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)