PMDA device listing

CT小児用シールド

PMDA Medical device listing · 13B3X10093001008 · Class I

Key facts

PMDA document key 171320_13B3X10093001008_1_01
Brand names CT小児用シールド
General names (JMDN) 放射線防護用掛布
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B3X10093001008
JMDN codes 38357000
Category code A1100
Marketing authorization holder 製造販売/フレア株式会社
Package insert date Jul 28, 2021
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)