PMDA device listing

ブラッドアクセス UK-カテーテルキット(クワッドルーメンカテーテル フルキットタイプ)

PMDA Medical device listing · 16100BZZ01735000 · Class III

Key facts

PMDA document key 530100_16100BZZ01735000_Q_01
Brand names ブラッドアクセス UK-カテーテルキット(クワッドルーメンカテーテル フルキットタイプ)
General names (JMDN) ウロキナーゼ使用緊急時ブラッドアクセス留置用カテーテル
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 16100BZZ01735000
JMDN codes 70320400
Category code A5100
Marketing authorization holder 製造販売/ニプロ株式会社
Package insert date Sep 9, 2026
Latest revision 2024-10
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)