PMDA device listing

905シリンジ

PMDA Medical device listing · 08B2X00001000011 · Class I

Key facts

PMDA document key 830035_08B2X00001000011_A_01
Brand names 905シリンジ
General names (JMDN) 歯科用口腔洗浄器
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 08B2X00001000011
JMDN codes 12304020
Category code A5500
Marketing authorization holder 製造販売/吉田精工株式会社
Package insert date Feb 26, 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
  • Yes 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:

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