PMDA device listing

溶解液注入針

PMDA Medical device listing · 27B1X00045000001 · Class I

Key facts

PMDA document key 530100_27B1X00045000001_B_01
Brand names 溶解液注入針
General names (JMDN) 薬液調整用針
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 27B1X00045000001
JMDN codes 70379000
Category code A7400
Marketing authorization holder 製造販売/ニプロ株式会社
Package insert date Nov 13, 2017
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)