PMDA device listing

Elite 吸引ボトル B3000P

PMDA Medical device listing · 13B2X10127000001 · Class I

Key facts

PMDA document key 670078_13B2X10127000001_A_01
Brand names Elite 吸引ボトル B3000P
General names (JMDN) 吸引器用ボトル
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B2X10127000001
JMDN codes 38476000
Category code A3200
Marketing authorization holder 製造販売/富士医療測器株式会社
Package insert date Aug 7, 2026
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)