Identity
- Trade Name
- i-PAD EUDAMED
- Device Name
- Defibrillator EUDAMED
- Model / Reference
- CU-SP1 PLUS EUDAMEDCSO-I-004-R1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809435480461 EUDAMED
- Basic UDI-DI
- B-08809435480461 EUDAMED
- EMDN Code
- Z12030501 SEMI-AUTOMATIC DEFIBRILLATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
i-PAD 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-08809435480461 | 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 1c5e35a3-a4b4-4a04-9555-38ccc94175fc 61 fields · synced May 21, 2026