PMDA device listing

LFSクイックセンサー

PMDA In vitro diagnostic listing · 21400AMY00194000 · Class III

Key facts

PMDA document key 841009_21400AMY00194000_A_10
Brand names LFSクイックセンサー
General names (JMDN) 自己検査用グルコースキット
Product type In vitro diagnostic
Device class (Japan) Class III
Approval, certification or notification number 21400AMY00194000
JMDN codes 30221003
Category code A0100
Marketing authorization holder 製造販売/LifeScan Japan株式会社
Package insert date May 25, 2026
Latest revision 2026-05
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)