PMDA device listing
Tec800シリーズ 気化器 イソフルラン（(ISO Tec850 / ISO Tec820)）
PMDA Medical device listing · 23000BZX00189000 · Class III
Key facts
| PMDA document key | 530979_23000BZX00189000_A_01 |
|---|---|
| Brand names | Tec800シリーズ 気化器 イソフルラン（(ISO Tec850 / ISO Tec820)） |
| General names (JMDN) | イソフルラン用麻酔薬気化器 |
| Product type | Medical device |
| Device class (Japan) | Class III |
| Approval, certification or notification number | 23000BZX00189000 |
| JMDN codes | 36890000 |
| Category code | A0500 |
| Marketing authorization holder | 製造販売／製造販売業者：GEヘルスケア・ジャパン株式会社住所： 〒191-8503 東京都日野市旭が丘4-7-127 |
| Package insert date | Apr 24, 2025 |
| Latest revision | 2025-04 |
| 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: