← Back to catalogue
Heart Guardian
EUDAMEDClass IIb (EU MDR)
Ref Heart Guardian HR-701
by Radianqbio
Identity
- Trade Name
- Heart Guardian EUDAMED
- Device Name
- Automated External Defibrillator EUDAMED
- Model / Reference
- Heart Guardian HR-701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809434320133 EUDAMED
- Basic UDI-DI
- B-08809434320133 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
Heart Guardian by Radianqbio — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08809434320133 | 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 070d37c0-e7c1-48ce-aa06-f990a7cda70a 61 fields · synced Jun 17, 2026