PMDA device listing

ケイセイスプーン型鋭匙及び鈍匙

PMDA Medical device listing · 15B1X00001000119 · Class I

Key facts

PMDA document key 260004_15B1X00001000119_A_01
Brand names ケイセイスプーン型鋭匙及び鈍匙
General names (JMDN) スプーン型鋭ひ及び鈍ひ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 15B1X00001000119
JMDN codes 41716001
Category code A3700
Marketing authorization holder 製造販売/ケイセイ医科工業株式会社
Package insert date Nov 28, 2017
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)