PMDA device listing

フレキシブルリーマー

PMDA Medical device listing · 21900BZX01120000 · Class II

Key facts

PMDA document key 670676_21900BZX01120000_A_01
Brand names フレキシブルリーマー
General names (JMDN) 外科手術用中空ドリル
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 21900BZX01120000
JMDN codes 11332000
Category code A5800
Marketing authorization holder 製造販売/株式会社アルファメッド
Package insert date Oct 29, 2024
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)