PMDA device listing

スタッカート SCP システム(電動クランプ)

PMDA Medical device listing · 21500BZG00006000 · Class III

Key facts

PMDA document key 390059_21500BZG00006000_U_01
Brand names スタッカート SCP システム(電動クランプ)
General names (JMDN) 体外循環装置用遠心ポンプ駆動装置
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 21500BZG00006000
JMDN codes 70523000
Category code A0700
Marketing authorization holder 製造販売/ソーリン・グループ株式会社
Package insert date Jul 9, 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)