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waveguard original
EUDAMEDClass I (EU MDR)
Ref CA-116Model CA-xxx/CY-xxx/CS-xxx/NA-xxx/NG-xxx/XC-xxx/XE-xxx/XS-xxx
Identity
- Trade Name
- waveguard original EUDAMED
- Device Name
- waveguard product family EUDAMED
- Model / Reference
- CA-xxx/CY-xxx/CS-xxx/NA-xxx/NG-xxx/XC-xxx/XE-xxx/XS-xxx EUDAMEDCA-116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B195CA116 EUDAMED
- Basic UDI-DI
- ++B195waveguard9J EUDAMED
- Direct Marketing DI
- +B195CA116 EUDAMED
- EMDN Code
- N01010203 EEG HEADSETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
waveguard original by Eemagine Medical Imaging Solutions Gmbh — 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 | ++B195waveguard9J | Class I | Active |
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Manufacturer
- Manufacturer
- eemagine Medical Imaging Solutions GmbH
- EUDAMED SRN
- DE-MF-000005560
Sources (1)
- EUDAMED 8a86047c-57b8-4fbb-a4aa-decbb29cea67 61 fields · synced Jun 19, 2026