PMDA device listing

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PMDA Medical device listing · 231AFBZX00032000 · Class II

Key facts

PMDA document key 130517_231AFBZX00032000_A_01
Brand names コントロールクリック
General names (JMDN) 輪状甲状膜切開キット
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 231AFBZX00032000
JMDN codes 15028000
Category code A5100
Marketing authorization holder 製造販売/株式会社インターメドジャパン
Package insert date Dec 4, 2023
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)