PMDA device listing

HAI上腕ネイルシステム用手術器械(7.0ボールレンチ)

PMDA Medical device listing · 20B1X00006H00038 · Class I

Key facts

PMDA document key 710116_20B1X00006H00038_A_06
Brand names HAI上腕ネイルシステム用手術器械(7.0ボールレンチ)
General names (JMDN) 手術用レンチ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 20B1X00006H00038
JMDN codes 32871000
Category code A5800
Marketing authorization holder 製造販売/株式会社ホムズ技研
Package insert date May 19, 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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