PMDA device listing

ラクテート・プロ LT-1710

PMDA Medical device listing · 25B1X00001000026 · Class I

Key facts

PMDA document key 100639_25B1X00001000026_A_01
Brand names ラクテート・プロ LT-1710
General names (JMDN) ラクテート分析装置
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 25B1X00001000026
JMDN codes 35885000
Category code A1700
Marketing authorization holder 製造販売/株式会社アークレイファクトリー
Package insert date Oct 28, 2011
Latest revision 2009-10
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
  • Yes 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:

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