Identity
- Device Name
- Defibrillation Electrode EUDAMED
- Model / Reference
- CUA1007S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809435481031 EUDAMED
- Basic UDI-DI
- B-08809435481031 EUDAMED
- EMDN Code
- C020401 EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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-08809435481031 | 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 (1)
- EUDAMED f028bd10-2b5e-4edd-8f29-181d77e037f9 61 fields · synced Jun 18, 2026