PMDA device listing

RFボーンマロウニードル(アスピレーション&ハーベストニードル)

PMDA Medical device listing · 305ADBZX00068000 · Class II

Key facts

PMDA document key 370118_305ADBZX00068000_A_01
Brand names RFボーンマロウニードル(アスピレーション&ハーベストニードル)
General names (JMDN) 骨髄生検キット
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 305ADBZX00068000
JMDN codes 16833000
Category code A4700
Marketing authorization holder 製造販売/スーガン株式会社
Package insert date Jul 23, 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)