PMDA device listing

ハイドロサイト プラス

PMDA Medical device listing · 22100BZX01097000 · Class III

Key facts

PMDA document key 371113_22100BZX01097000_A_02
Brand names ハイドロサイト プラス
General names (JMDN) 二次治癒フォーム状創傷被覆・保護材
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 22100BZX01097000
JMDN codes 11323003
Category code B0400
Marketing authorization holder 製造販売/スミス・アンド・ネフュー株式会社
Package insert date May 7, 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)