Identity
- Trade Name
- AIVIA EUDAMED
- Device Name
- Aivia V3 Protection model 210 EUDAMED
- Model / Reference
- X3A210-XX101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770023276030 EUDAMED
- Basic UDI-DI
- 37700AIVIA-V3-2105D EUDAMED
- Direct Marketing DI
- 03770023276030 EUDAMED
- EMDN Code
- C020480 CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Wearable defibrillation system
Aivia by Pyrescom — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 37700AIVIA-V3-2105D | Class I | Active |
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Manufacturer
- Manufacturer
- Pyrescom
- EUDAMED SRN
- FR-MF-000007671
Sources (1)
- EUDAMED 2b2b0fa8-818c-4605-ada0-3a8400047c6d 61 fields · synced Jun 19, 2026