PMDA device listing

MKwedgeBlade 一体型 S-miyatani 角度6度

PMDA Medical device listing · 38B2X10004M00013 · Class I

Key facts

PMDA document key 750707_38B2X10004M00013_A_03
Brand names MKwedgeBlade 一体型 S-miyatani 角度6度
General names (JMDN) 手術用のこぎり
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 38B2X10004M00013
JMDN codes 13448001
Category code A4000
Marketing authorization holder 製造販売/株式会社ミヤタニ
Package insert date Oct 24, 2022
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:

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