PMDA device listing

マイショット

PMDA Medical device listing · 15700BZZ00211000 · Class III

Key facts

PMDA document key 530100_15700BZZ00211000_A_01
Brand names マイショット
General names (JMDN) インスリン皮下投与用針付注射筒
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 15700BZZ00211000
JMDN codes 35389020
Category code A4800
Marketing authorization holder 製造販売/ニプロ株式会社
Package insert date Aug 10, 2026
Latest revision 2023-10
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)