PMDA device listing

テノン針

PMDA Medical device listing · 13B3X00319000023 · Class I

Key facts

PMDA document key 480278_13B3X00319000023_A_01
Brand names テノン針
General names (JMDN) 洗浄針
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B3X00319000023
JMDN codes 70459000
Category code A5501
Marketing authorization holder 製造販売/株式会社都北医療器製作所
Package insert date Jun 25, 2021
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)