PMDA device listing

MySpine Cervical PSガイド

PMDA Medical device listing · 30100BZX00248000 · Class II

Key facts

PMDA document key 784570_30100BZX00248000_A_01
Brand names MySpine Cervical PSガイド
General names (JMDN) 患者適合型単回使用骨手術用器械
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 30100BZX00248000
JMDN codes 70962212
Category code A5800
Marketing authorization holder 製造販売/メダクタジャパン株式会社
Package insert date Sep 1, 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
  • 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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