PMDA device listing

アイボタンR

PMDA Medical device listing · 22700BZX00302000 · Class III

Key facts

PMDA document key 480273_22700BZX00302000_A_04
Brand names アイボタンR
General names (JMDN) 長期的使用経腸栄養キット
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 22700BZX00302000
JMDN codes 11677003
Category code A5100
Marketing authorization holder 製造販売/株式会社トップ
Package insert date Sep 10, 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)