PMDA device listing

ベルテキマックスセブンスセンスSF-5300

PMDA Medical device listing · 11B2X10024000002 · Class I

Key facts

PMDA document key 750634_11B2X10024000002_C_01
Brand names ベルテキマックスセブンスセンスSF-5300
General names (JMDN) 非天然ゴム製検査・検診用手袋
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 11B2X10024000002
JMDN codes 70976000
Category code B0300
Marketing authorization holder 製造販売/ミドリ安全用品株式会社
Package insert date Jul 28, 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
  • 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)