Identity
- Trade Name
- X-Series System (Stat) EUDAMED
- Device Name
- X-Series System EUDAMED
- Model / Reference
- 30-4222 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00851113007789 EUDAMED
- Basic UDI-DI
- 0851113007XS30ACCVR EUDAMED
- EMDN Code
- N01010203 EEG HEADSETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
X-Series System (Stat) by Advanced Brain Monitoring, Inc. — Class I — 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 | 0851113007XS30ACCVR | Class I | Active |
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Manufacturer
- Manufacturer
- Advanced Brain Monitoring, Inc.
- EUDAMED SRN
- US-MF-000011252
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 5e1835b3-323e-4fdf-a513-7ccec6be2278 61 fields · synced Jun 18, 2026