PMDA device listing

トーマ血球計算盤

PMDA Medical device listing · 11B3X00039A10020 · Class I

Key facts

PMDA document key 300712_11B3X00039A10020_B_01
Brand names トーマ血球計算盤
General names (JMDN) 手動式血球計数装置
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 11B3X00039A10020
JMDN codes 35103000
Category code A1701
Marketing authorization holder 製造販売/サンリード硝子有限会社
Package insert date Jul 6, 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:

Browse all PMDA medical device and IVD listings (Japan)