Identity
- Trade Name
- HFe501 DR EUDAMED
- Device Name
- HFe501 DR EUDAMED
- Model / Reference
- HFe501 DR EUDAMED21402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262425760136 EUDAMED
- Basic UDI-DI
- 42624257621402M8 EUDAMED
- EMDN Code
- Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Humanmedizinische Projektionsradiographie an Erwachsenen und Kindern. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, analogue
HFe501 DR by BRS-Brieden Radiologische Systemlösungen GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stationary basic diagnostic x-ray system, analogue.
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- SEDECAL — Sedecal., Sa. · Class II
- Q-RAD System — CARESTREAM HEALTH, INC. · Class II
- X-CEL X-RAY CORPORATION — ARQUILLA, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- FDR Smart FGXR-E32S — DRGEM Corporation · Class IIb
- DRGEM — DRGEM Corporation · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42624257621402M8 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BRS-Brieden Radiologische Systemlösungen GmbH
- EUDAMED SRN
- DE-PR-000005037
Sources (1)
- EUDAMED 992caea2-6cc1-4195-a4bc-57541081b0e9 61 fields · synced Jul 13, 2026