PMDA device listing

Dr.ヘルス ハーモナズ

PMDA Medical device listing · 301AKBZX00079A01 · Class II

Key facts

PMDA document key 100324_301AKBZX00079A01_1_01
Brand names Dr.ヘルス ハーモナズ
General names (JMDN) 家庭用永久磁石磁気治療器
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 301AKBZX00079A01
JMDN codes 71016000
Category code A8102
Marketing authorization holder 製造販売/アポロ医療器株式会社
Package insert date Jan 17, 2022
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:

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