PMDA device listing

酸素流量計付湿潤器F-315

PMDA Medical device listing · 39B2X00003001036 · Class I

Key facts

PMDA document key 270391_39B2X00003001036_1_01
Brand names 酸素流量計付湿潤器F-315
General names (JMDN) 非加熱式加湿器
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 39B2X00003001036
JMDN codes 35113000
Category code A7600
Marketing authorization holder 製造販売/小松精機株式会社
Package insert date Jul 15, 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)