Identity
- Device Name
- Kneuro App EUDAMED
- Model / Reference
- SW-Kneuro-BR4-AP EUDAMEDSW-Kneuro-BR4-AN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850070871020 EUDAMED00850070871037 EUDAMED
- Basic UDI-DI
- 0850070871KneuroAppFY EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Kneuro App by BrainPortfolio Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850070871KneuroAppFY | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BrainPortfolio Inc.
- EUDAMED SRN
- US-MF-000046032
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 3a7fc562-bd1d-4089-b535-8c97fb6b0f15 61 fields · synced Jul 10, 2026
- EUDAMED 4e429f8b-fcb7-4590-90ba-7e602239b5ff 61 fields · synced May 19, 2026