PMDA device listing

オムロン手首式血圧計HEM-6230シリーズ(HEM-6233T)

PMDA Medical device listing · 230AGBZX00003000 · Class II

Key facts

PMDA document key 180860_230AGBZX00003000_A_03
Brand names オムロン手首式血圧計HEM-6230シリーズ(HEM-6233T)
General names (JMDN) 自動電子血圧計
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 230AGBZX00003000
JMDN codes 16173000
Category code A1800
Marketing authorization holder 製造販売/オムロンヘルスケア株式会社
Package insert date Jul 9, 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:

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