PMDA device listing

テルモシリンジ

PMDA Medical device listing · 13B1X00101000022 · Class I

Key facts

PMDA document key 470034_13B1X00101000022_A_01
Brand names テルモシリンジ
General names (JMDN) 汎用注射筒
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00101000022
JMDN codes 13929001
Category code A4800
Marketing authorization holder 製造販売/テルモ株式会社
Package insert date Apr 1, 2022
Latest revision 2017-08
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)