PMDA device listing

SNユニット エクセレンス 両側

PMDA Medical device listing · 22100BZX00350000 · Class II

Key facts

PMDA document key 510027_22100BZX00350000_1_01
Brand names SNユニット エクセレンス 両側
General names (JMDN) 耳鼻咽喉科用治療ユニット
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 22100BZX00350000
JMDN codes 11585000
Category code A0100
Marketing authorization holder 製造販売/永島医科器械株式会社
Package insert date Jul 13, 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)