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En_neurophet Aqua V1.0
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref EN_NEUROPHET AQUA V1.0Model Neurophet AQUA
Identity
- Model / Reference
- Neurophet AQUA EUDAMEDEN_NEUROPHET AQUA V1.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800130400105 EUDAMED
- Basic UDI-DI
- B-08800130400105 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Northern Ireland 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
En_neurophet Aqua V1.0 by NEUROPHET Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K261273 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K220437 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800130400105 | Class IIa | Active |
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Manufacturer
- Manufacturer
- NEUROPHET, Inc.
- EUDAMED SRN
- KR-MF-000019879
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 09395dee-f8ce-4109-9174-06dc4005c1c2 61 fields · synced Jul 14, 2026
- FDA 510(k) K261273 1 fields · synced May 29, 2026