PMDA device listing

ヘラベスト M プリント プラス

PMDA Medical device listing · 27B1X00060000080 · Class I

Key facts

PMDA document key 700102_27B1X00060000080_1_01
Brand names ヘラベスト M プリント プラス
General names (JMDN) 歯科高温鋳造用埋没材
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 27B1X00060000080
JMDN codes 70900020
Category code C0800
Marketing authorization holder 製造販売/クルツァー ジャパン 株式会社
Package insert date Jun 12, 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
  • 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)