PMDA device listing

アトム酸素テント

PMDA Medical device listing · 11B1X00002Z06003 · Class I

Key facts

PMDA document key 100144_11B1X00002Z06003_0_85
Brand names アトム酸素テント
General names (JMDN) 酸素テント
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 11B1X00002Z06003
JMDN codes 12893000
Category code A0600
Marketing authorization holder 製造販売/アトムメディカル株式会社
Package insert date Dec 21, 2017
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)