PMDA device listing
ホルター心電計 RootiRx
PMDA Medical device listing · 305AFBZX00065000 · Class II
Key facts
| PMDA document key | 380774_305AFBZX00065000_2_02 |
|---|---|
| Brand names | ホルター心電計 RootiRx |
| General names (JMDN) | 長時間心電用データレコーダ |
| Product type | Medical device |
| Device class (Japan) | Class II |
| Approval, certification or notification number | 305AFBZX00065000 |
| JMDN codes | 35162000 |
| Category code | A2100 |
| Marketing authorization holder | 製造販売／セティ株式会社 |
| Package insert date | Mar 27, 2026 |
| 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: