PMDA device listing

けんだくボトルB型300ml

PMDA Medical device listing · 07B3X10010000006 · Class I

Key facts

PMDA document key 343169_07B3X10010000006_1_01
Brand names けんだくボトルB型300ml
General names (JMDN) 経腸栄養注入セット
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 07B3X10010000006
JMDN codes 70400000
Category code A7400
Marketing authorization holder 製造販売/診療化成株式会社
Package insert date Apr 20, 2023
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)