PMDA device listing

ヘッドハガー モデル455

PMDA Medical device listing · 13B1X00226000011 · Class I

Key facts

PMDA document key 670397_13B1X00226000011_A_01
Brand names ヘッドハガー モデル455
General names (JMDN) 成形副木
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00226000011
JMDN codes 35354000
Category code B0500
Marketing authorization holder 製造販売/ファーノ・ジャパン・インク
Package insert date Jan 25, 2022
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:

Browse all PMDA medical device and IVD listings (Japan)