PMDA device listing

UltraCor Twirl ブレスト マーカー

PMDA Medical device listing · 23000BZX00313000 · Class III

Key facts

PMDA document key 780045_23000BZX00313000_A_01
Brand names UltraCor Twirl ブレスト マーカー
General names (JMDN) 植込み型病変識別マーカ
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 23000BZX00313000
JMDN codes 40808000
Category code B0400
Marketing authorization holder 製造販売/株式会社メディコン
Package insert date Aug 26, 2026
Latest revision 2026-08
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:

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