PMDA device listing

スパーテルカバーN

PMDA Medical device listing · 13B1X10482I40039 · Class I

Key facts

PMDA document key 710130_13B1X10482I40039_A_01
Brand names スパーテルカバーN
General names (JMDN) 医療用不織布
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X10482I40039
JMDN codes 34655000
Category code B0400
Marketing authorization holder 製造販売/株式会社ホギメディカル
Package insert date Oct 1, 2026
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)