HDE
BH110018106: CliniMACS CD34 Reagent System
FDA Humanitarian Device Exemption · miltenyi biotec, inc.
Key facts
| HDE number | BH110018106 |
|---|---|
| Trade name | CliniMACS CD34 Reagent System |
| Applicant | miltenyi biotec, inc. |
| Approval date | Jun 6, 2025 |
At a glance
- None Supplements
- Jun 6, 2025 Latest supplement decision
- No Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: