PMDA device listing
HB-IVRガイドワイヤ4
PMDA Medical device listing · 30600BZX00163000 · Class IV
Key facts
| PMDA document key | 670513_30600BZX00163000_A_01 |
|---|---|
| Brand names | HB-IVRガイドワイヤ4 |
| General names (JMDN) | 心臓・中心循環系用カテーテルガイドワイヤ |
| Product type | Medical device |
| Device class (Japan) | Class IV |
| Approval, certification or notification number | 30600BZX00163000 |
| JMDN codes | 35094114 |
| Category code | A5100 |
| Marketing authorization holder | 製造販売／製造販売業者：フィルメック株式会社住所：愛知県瀬戸市暁町3番地99 |
| Package insert date | Jul 25, 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
- 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: