PMDA device listing

小児用輸液セット

PMDA Medical device listing · 11B1X00016000224 · Class I

Key facts

PMDA document key 380082_11B1X00016000224_B_01
Brand names 小児用輸液セット
General names (JMDN) 自然落下式針なし輸液セット
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 11B1X00016000224
JMDN codes 70370000
Category code A7400
Marketing authorization holder 製造販売/泉工医科工業株式会社
Package insert date May 30, 2017
Latest revision 2016-02
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)