Identity
- Trade Name
- Brain Health EUDAMED
- Device Name
- Brain Health EUDAMED
- Model / Reference
- 1.y.z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860005144075 EUDAMED
- Basic UDI-DI
- 8600051440023T3 EUDAMED
- Direct Marketing DI
- 00860005144075 EUDAMED
- EMDN Code
- Z119082 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Brain Health by Deephealth — Class IIa — 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 | 8600051440023T3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- DeepHealth, Inc.
- EUDAMED SRN
- US-MF-000051664
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 740fbebf-3fea-44e1-b36a-54e15309ea5c 61 fields · synced Jul 11, 2026