PMDA device listing

プライトン‐100

PMDA Medical device listing · 13B1X00207000039 · Class I

Key facts

PMDA document key 480051_13B1X00207000039_A_01
Brand names プライトン‐100
General names (JMDN) ギプス包帯
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00207000039
JMDN codes 33056000
Category code B0402
Marketing authorization holder 製造販売/アルケア株式会社
Package insert date Jan 25, 2017
Latest revision 2016-07
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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