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Heart Guardian
EUDAMEDClass IIb (EU MDR)
Ref Heart Guardian HR-701 BRef Heart Guardian HR-701 ARef Heart Guardian HR-701 PlusRef Heart Guardian HR-701 Plus A
by Radianqbio
Identity
- Trade Name
- Heart Guardian EUDAMED
- Device Name
- Automated External Defibrillator EUDAMED
- Model / Reference
- Heart Guardian HR-701 B EUDAMEDHeart Guardian HR-701 A EUDAMEDHeart Guardian HR-701 Plus EUDAMEDHeart Guardian HR-701 Plus A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809434320157 EUDAMED08809434320140 EUDAMED08809434320164 EUDAMED08809434320171 EUDAMED
- Basic UDI-DI
- B-08809434320157 EUDAMEDB-08809434320140 EUDAMEDB-08809434320164 EUDAMEDB-08809434320171 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
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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-08809434320157 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Radianqbio
- EUDAMED SRN
- KR-MF-000013678
- Authorised Representative
- S.B. Pharma GmbH DE-AR-000005392
Sources (4)
- EUDAMED 2be2766a-f2a5-4c80-9645-8f18fda6d662 61 fields · synced Jul 31, 2026
- EUDAMED 64b62f2e-3455-4fce-a154-b4ec6fbe3582 61 fields · synced May 17, 2026
- EUDAMED 056c424a-8a78-4ce8-90a9-f9c1bfffca4c 61 fields · synced May 18, 2026
- EUDAMED 77202f0b-5ab1-4a4a-b9d7-63902faa42b3 61 fields · synced May 18, 2026