PMDA device listing

肺動脈圧、中心動脈圧測定用カテーテル

PMDA Medical device listing · 15700BZY00397000 · Class III

Key facts

PMDA document key 100358_15700BZY00397000_1_01
Brand names 肺動脈圧、中心動脈圧測定用カテーテル
General names (JMDN) 肺動脈用カテーテル
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 15700BZY00397000
JMDN codes 35889000
Category code A5100
Marketing authorization holder 製造販売/製造販売業者テレフレックスメディカルジャパン株式会社
Package insert date Nov 20, 2023
Latest revision 2023-09
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)