← Back to catalogue
Grael
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9028-0001-02Model Grael v2 System, No Software
Identity
- Trade Name
- Compumedics Grael FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Grael EUDAMEDGrael v2 System, no software FDA UDI
- Model / Reference
- Grael v2 System, No Software EUDAMED9028-0001-02 EUDAMEDGrael FDA UDI
- Description
- Grael v2 System, no software FDA UDI
Identifiers
- Catalog Number
- 9028-0001-02 FDA UDI
- Primary DI / UDI-DI
- 09342451001276 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09342451001276 EUDAMED
- 510(k) Number
- K093223 FDA UDI
- FDA Product Code
- GWQ FDA UDIOLV FDA UDI
- EMDN Code
- Z12100302,Z12100501 EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Grael by Compumedics Limited — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09342451001276 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Compumedics Limited
- EUDAMED SRN
- AU-MF-000050437
- Authorised Representative
- Compumedics EUROPE GmbH DE-AR-000039096
Sources (2)
- EUDAMED 7165a963-ef01-46a7-9412-7a746a41af92 61 fields · synced May 30, 2026
- FDA UDI d00f464e-2fed-4108-90ab-ef8d2e8f5094 37 fields · synced May 30, 2026