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128 Channel Geodesic EEG System (GES) 400 Portable
EUDAMEDClass IIa (EU MDR)
Ref 1401282
by Magstim Inc.
Identity
- Trade Name
- 128 Channel Geodesic EEG System (GES) 400 Portable EUDAMED
- Device Name
- 128 Channel Geodesic EEG System (GES) 400 Portable EUDAMED
- Model / Reference
- 1401282 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1401282V6 EUDAMED
- Basic UDI-DI
- B-1401282V6 EUDAMED
- EMDN Code
- Z12100303 SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
128 Channel Geodesic EEG System (GES) 400 Portable by Magstim Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-1401282V6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Magstim Inc.
- EUDAMED SRN
- US-MF-000024844
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 06685b38-b4e8-47fe-a022-c53479386ff6 61 fields · synced Jul 31, 2026