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Pediatric Defibrillation Electrode
EUDAMEDClass IIb (EU MDR)
Ref CUA0711PRef CUA0508ORef CUA0512PRef CUA0809PARef CUA1102S
Identity
- Device Name
- Pediatric Defibrillation Electrode EUDAMEDDefibrillation Electrode EUDAMED
- Model / Reference
- CUA0711P EUDAMEDCUA0508O EUDAMEDCUA0512P EUDAMEDCUA0809PA EUDAMEDCUA1102S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809435480096 EUDAMED08809435482632 EUDAMED08809435482106 EUDAMED08809435483035 EUDAMED08809435481048 EUDAMED
- Basic UDI-DI
- B-08809435480096 EUDAMEDB-08809435482632 EUDAMEDB-08809435482106 EUDAMEDB-08809435483035 EUDAMEDB-08809435481048 EUDAMED
- EMDN Code
- C020401 EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Pediatric 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-08809435480096 | 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 (5)
- EUDAMED 37066bd5-10e0-44f9-be40-386826b6296b 61 fields · synced Jul 19, 2026
- EUDAMED f570aba0-c2ec-4df2-ba47-4b98aa00cf06 61 fields · synced May 17, 2026
- EUDAMED dae5a917-c9cb-49a7-b1e6-44e28f549a93 61 fields · synced May 18, 2026
- EUDAMED 9248369d-4087-493b-a40c-240d44580b76 61 fields · synced May 18, 2026
- EUDAMED ee4c4bcf-906f-4138-906c-b984983322d0 61 fields · synced May 18, 2026