← Back to catalogue
i-PAD
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref CSO-I-004-R1Model NF1200510(k) K062970Model NFK200Model NF1201Model CU-SP1 AUTOModel CU-SP1
Identity
- Trade Name
- i-PAD EUDAMED
- Device Name
- Defibrillator EUDAMED
- Model / Reference
- NF1200 EUDAMEDCSO-I-004-R1 EUDAMEDNFK200 EUDAMEDNF1201 EUDAMEDCU-SP1 AUTO EUDAMEDCU-SP1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809435482014 EUDAMED08809435482021 EUDAMED08809435482038 EUDAMED08809435480485 EUDAMED08809435481000 EUDAMED
- Basic UDI-DI
- B-08809435482014 EUDAMEDB-08809435482021 EUDAMEDB-08809435482038 EUDAMEDB-08809435480485 EUDAMEDB-08809435481000 EUDAMED
- EMDN Code
- Z12030501 SEMI-AUTOMATIC DEFIBRILLATORS EUDAMEDZ12030503 AUTOMATIC DEFIBRILLATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMEDGermany EUDAMEDFrance 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
i-PAD by CU Medical Systems, Inc. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062970 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809435482014 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CU Medical Systems, Inc.
- EUDAMED SRN
- KR-MF-000018333
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (6)
- EUDAMED 5ed97293-f3ab-4159-a276-dd4b1d9bd39b 85 fields · synced Sep 18, 2026
- EUDAMED cb6886e7-cf55-490b-887e-53938f3a7fff 61 fields · synced May 17, 2026
- EUDAMED aaaaf407-4d81-4b3e-8552-5d84d94b457c 61 fields · synced May 19, 2026
- EUDAMED 48aa1087-128f-4821-8e8a-e6bc7d27243a 61 fields · synced May 19, 2026
- EUDAMED b3b785bf-74e2-4f2d-b4c7-d06b8a02efd7 61 fields · synced May 19, 2026
- FDA 510(k) K062970 1 fields · synced May 18, 2026