PMDA device listing

HeliCool V CXB−500B

PMDA Medical device listing · 226ADBZX00224000 · Class II

Key facts

PMDA document key 480848_226ADBZX00224000_A_01
Brand names HeliCool V CXB−500B
General names (JMDN) X線管装置
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 226ADBZX00224000
JMDN codes 35618000
Category code A0900
Marketing authorization holder 製造販売/キヤノン電子管デバイス株式会社
Package insert date Nov 1, 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:

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