PMDA device listing

フレアグリッド フルガード

PMDA Medical device listing · 13B3X10093002004 · Class I

Key facts

PMDA document key 171320_13B3X10093002004_1_01
Brand names フレアグリッド フルガード
General names (JMDN) X線用グリッド
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B3X10093002004
JMDN codes 40914000
Category code A0908
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)