PMDA device listing

スパインポジショニングシステム

PMDA Medical device listing · 27B3X00274000004 · Class I

Key facts

PMDA document key 784800_27B3X00274000004_S_01
Brand names スパインポジショニングシステム
General names (JMDN) 手術台アクセサリー
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 27B3X00274000004
JMDN codes 70469000
Category code A0100
Marketing authorization holder 製造販売/GEMSS JAPAN株式会社
Package insert date Jan 8, 2016
Latest revision 2016-01
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)