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Brain Age

EUDAMED

Class IIa (EU MDR)

Ref V.1.y.zModel 1.y.z

by DeepHealth, Inc.

Identity

Trade Name
Brain Age EUDAMED
Device Name
Brain Age EUDAMED
Model / Reference
1.y.z EUDAMED
V.1.y.z EUDAMED

Identifiers

Primary DI / UDI-DI
00860005144082 EUDAMED
Basic UDI-DI
8600051440026T9 EUDAMED
EMDN Code
Z119082 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Austria 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 Age 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

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Manufacturer

Manufacturer
DeepHealth, Inc.
EUDAMED SRN
US-MF-000051664
Authorised Representative
MedEnvoy Global BV NL-AR-000024028

Sources (1)

  • EUDAMED 0489d777-4158-4eb6-8fca-48e3f5f45c22 61 fields · synced Jul 9, 2026