← Back to catalogue
Heart Guardian
EUDAMEDClass IIb (EU MDR)
Ref Heart Guardian HR-501
by Radianqbio
Identity
- Trade Name
- Heart Guardian EUDAMED
- Device Name
- Automated External Defibrillator EUDAMED
- Model / Reference
- Heart Guardian HR-501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809434320003 EUDAMED
- Basic UDI-DI
- B-08809434320003 EUDAMED
- EMDN Code
- C020480 CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Wearable defibrillation system
Heart Guardian by Radianqbio — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wearable defibrillation system.
- DESFI-DORMO — Telic, S.A.U. · Class I
- DESFI-DORMO — Telic, S.A.U. · Class I
- DESFI-DORMO — Telic, S.A.U. · Class I
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
- DESFI-DORMO — Telic, S.A.U. · Class I
- Hospital Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
- DESFI-DORMO — Telic, S.A.U. · Class I
- DESFI-DORMO — Telic, S.A.U. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809434320003 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Radianqbio
- EUDAMED SRN
- KR-MF-000013678
- Authorised Representative
- S.B. Pharma GmbH DE-AR-000005392
Sources (1)
- EUDAMED b2821175-6def-4b56-89bc-ea659fe3a400 61 fields · synced Jun 18, 2026