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Grael

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 9028-0020-02Model Grael PSG Package -Grael PG, PSG Starter KitRef 9028-0050-01Model Grael DC Assembly with Cable510(k) K093223

by Compumedics Limited

Identity

Device Name
Grael EUDAMED
Model / Reference
Grael PSG Package -Grael PG, PSG Starter Kit EUDAMED
9028-0020-02 EUDAMED
Grael DC Assembly with Cable EUDAMED
9028-0050-01 EUDAMED

Identifiers

Primary DI / UDI-DI
09342451006776 EUDAMED
09342451006769 EUDAMED
Basic UDI-DI
B-09342451006776 EUDAMED
B-09342451006769 EUDAMED
510(k) Number
K093223 FDA 510(k)
FDA Product Code
GWQ FDA 510(k)
EMDN Code
Z12100501 POLYSOMNOGRAPHS EUDAMED
Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1400 FDA 510(k)
Regulation Number
882.1400 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Grael by Compumedics Limited — 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

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Compumedics Limited
EUDAMED SRN
AU-MF-000050437
Authorised Representative
Compumedics EUROPE GmbH DE-AR-000039096

Sources (3)

  • EUDAMED d30775bd-c9f5-48ef-a4b5-29375764111f 61 fields · synced Jul 28, 2026
  • EUDAMED f89b29cc-1360-4a3a-9c2f-cdf4173f4014 61 fields · synced May 18, 2026
  • FDA 510(k) K093223 24 fields · synced May 18, 2026