PMDA device listing
「ＳｅｎＳｍａｒｔ 酸素飽和度モニターＸ−１００」の付属品（rSO2センサー 大人用、rSO2センサー 小児用）（rSO 2 センサー 大人用、rSO 2 センサー 小児用）
PMDA Medical device listing · 228AABZX00053000 · Class II
Key facts
| PMDA document key | 470034_228AABZX00053000_B_01 |
|---|---|
| Brand names | 「ＳｅｎＳｍａｒｔ 酸素飽和度モニターＸ−１００」の付属品（rSO2センサー 大人用、rSO2センサー 小児用）（rSO 2 センサー 大人用、rSO 2 センサー 小児用） |
| General names (JMDN) | 機能検査オキシメータ |
| Product type | Medical device |
| Device class (Japan) | Class II |
| Approval, certification or notification number | 228AABZX00053000 |
| JMDN codes | 70080000 |
| Category code | A1700 |
| Marketing authorization holder | 製造販売／テルモ株式会社 |
| Package insert date | Apr 12, 2023 |
| Latest revision | 2016-06 |
| 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: