PMDA device listing

APTUS Ankle Trauma アナトミカルトライロックプレート(滅菌)

PMDA Medical device listing · 30400BZX00096000 · Class II, Class III

Key facts

PMDA document key 784958_30400BZX00096000_A_01
Brand names APTUS Ankle Trauma アナトミカルトライロックプレート(滅菌)
General names (JMDN) 体内固定用プレート
Product type Medical device
Device class (Japan) Class II, Class III
Approval, certification or notification number 30400BZX00096000
JMDN codes 35241003, 16101003, 36198003, 36249002
Category code B0400
Marketing authorization holder 製造販売/メダティス株式会社
Package insert date May 28, 2026
Latest revision 2026-05
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:

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