PMDA device listing

テコフレックス尿管ステント

PMDA Medical device listing · 227ABBZX00063000 · Class II

Key facts

PMDA document key 180590_227ABBZX00063000_A_01
Brand names テコフレックス尿管ステント
General names (JMDN) 短期使用尿管用チューブステント
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 227ABBZX00063000
JMDN codes 34926022
Category code A5100
Marketing authorization holder 製造販売/オリンパスメディカルシステムズ株式会社
Package insert date Jan 25, 2023
Latest revision 2018-07
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:

Browse all PMDA medical device and IVD listings (Japan)