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LifeVest Wearable Defibrillator, Model 4000
EUDAMEDClass I (EU MDR)
Ref 11A1004
Identity
- Trade Name
- LifeVest Wearable Defibrillator, Model 4000 EUDAMED
- Device Name
- LifeVest Wearable Defibrillator - Battery Charger EUDAMED
- Model / Reference
- 11A1004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00855778005418 EUDAMED
- Basic UDI-DI
- 0855778005P010030BC75 EUDAMED
- Direct Marketing DI
- 00855778005418 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
LifeVest Wearable Defibrillator, Model 4000 by ZOLL Manufacturing Corporation — 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 | 0855778005P010030BC75 | Class I | Active |
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Manufacturer
- Manufacturer
- ZOLL Manufacturing Corporation
- EUDAMED SRN
- US-MF-000027987
- Authorised Representative
- ZOLL International Holding B.V. NL-AR-000012554
Sources (1)
- EUDAMED 60f02565-5e72-4c66-b478-6e7dc9dc4b71 61 fields · synced Aug 2, 2026