PMDA device listing

セレキャストスーパーR

PMDA Medical device listing · 27B3X00163000010 · Class I

Key facts

PMDA document key 160183_27B3X00163000010_A_01
Brand names セレキャストスーパーR
General names (JMDN) 歯科技工用アーク鋳造器
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 27B3X00163000010
JMDN codes 70752000
Category code A7000
Marketing authorization holder 製造販売/株式会社ウェイナ総合研究所
Package insert date Sep 1, 2021
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:

Browse all PMDA medical device and IVD listings (Japan)