PMDA device listing

血糖測定回路

PMDA Medical device listing · 16200BZZ01681000 · Class II

Key facts

PMDA document key 130061_16200BZZ01681000_A_01
Brand names 血糖測定回路
General names (JMDN) 採血セット
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 16200BZZ01681000
JMDN codes 10426000
Category code A5600
Marketing authorization holder 製造販売/フォルテグロウメディカル株式会社
Package insert date Nov 1, 2017
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)