PMDA device listing
HAI鎖骨ロッキングプレートシステム用手術器械（2.0ドリルスリーブ（L）、仮固定用ドリルスリーブ、仮固定用ガイドピンスリーブ）
PMDA Medical device listing · 20B1X00006H00026 · Class I
Key facts
| PMDA document key | 710116_20B1X00006H00026_A_16 |
|---|---|
| Brand names | HAI鎖骨ロッキングプレートシステム用手術器械（2.0ドリルスリーブ（L）、仮固定用ドリルスリーブ、仮固定用ガイドピンスリーブ） |
| General names (JMDN) | 手術用ドリルビットガイド |
| Product type | Medical device |
| Device class (Japan) | Class I |
| Approval, certification or notification number | 20B1X00006H00026 |
| JMDN codes | 35095000 |
| Category code | A5800 |
| Marketing authorization holder | 製造販売／株式会社ホムズ技研 |
| Package insert date | Apr 20, 2022 |
| 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: