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Defibrillation Electrode
EUDAMEDClass IIb (EU MDR)
Ref CUA1904SRef CUA0903PFRef CUA0512F
Identity
- Device Name
- Defibrillation Electrode EUDAMED
- Model / Reference
- CUA1904S EUDAMEDCUA0903PF EUDAMEDCUA0512F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809435481215 EUDAMED08809435482083 EUDAMED08809435482090 EUDAMED
- Basic UDI-DI
- B-08809435481215 EUDAMEDB-08809435482083 EUDAMEDB-08809435482090 EUDAMED
- EMDN Code
- C020401 EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDItaly 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
Defibrillation Electrode by CU Medical Systems, Inc. — 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-08809435481215 | Class IIb | Active |
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Manufacturer
- Manufacturer
- CU Medical Systems, Inc.
- EUDAMED SRN
- KR-MF-000018333
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED b1f76322-c4c1-48f2-b6ca-c321a56d3455 61 fields · synced Jul 28, 2026
- EUDAMED 05126a19-46d4-4c22-95ca-92621ccab00b 61 fields · synced May 17, 2026
- EUDAMED 40704b9b-95f6-47c1-9cb1-1dcf7e495ded 61 fields · synced May 18, 2026