PMDA device listing

東大式骨穿刺器-セット

PMDA Medical device listing · 11B1X00016000197 · Class I

Key facts

PMDA document key 380082_11B1X00016000197_A_01
Brand names 東大式骨穿刺器-セット
General names (JMDN) 再使用可能な生検用針
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 11B1X00016000197
JMDN codes 31730000
Category code A4700
Marketing authorization holder 製造販売/泉工医科工業株式会社
Package insert date Dec 6, 2018
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)