PMDA device listing

COOK尿路カテーテル(トロッカーニードル)

PMDA Medical device listing · 15700BZY00772000 · Class III

Key facts

PMDA document key 250288_15700BZY00772000_S_05
Brand names COOK尿路カテーテル(トロッカーニードル)
General names (JMDN) 長期的使用腎瘻用カテーテル
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 15700BZY00772000
JMDN codes 10735003
Category code A5100
Marketing authorization holder 製造販売/クックメディカルジャパン合同会社
Package insert date Apr 1, 2020
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)