PMDA device listing

SF3003R老眼鏡

PMDA Medical device listing · 18B3X00004AT0045 · Class I

Key facts

PMDA document key 170390_18B3X00004AT0045_A_01
Brand names SF3003R老眼鏡
General names (JMDN) 眼鏡
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 18B3X00004AT0045
JMDN codes 35065000
Category code A7100
Marketing authorization holder 製造販売/株式会社エニックス
Package insert date Jan 11, 2023
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:

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