PMDA device listing

口腔外科キット

PMDA Medical device listing · 21300BZZ00137000 · Class IV

Key facts

PMDA document key 710130_21300BZZ00137000_A_01
Brand names 口腔外科キット
General names (JMDN) 単回使用クラスIV処置キット
Product type Medical device
Device class (Japan) Class IV
Approval, certification or notification number 21300BZZ00137000
JMDN codes 33961004
Category code B0200
Marketing authorization holder 製造販売/株式会社ホギメディカル
Package insert date Jun 23, 2026
Latest revision 2026-06
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 10–99 Package insert revisions
  • 1–9 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:

Browse all PMDA medical device and IVD listings (Japan)