Identity
- Trade Name
- eego amplifier FDA UDI
- Generic Name
- Electroencephalographic signal amplifier FDA UDI
- Device Name
- physiological signal amplfier FDA UDI
- Model / Reference
- EE-211 FDA UDI
- Description
- physiological signal amplfier FDA UDI
Identifiers
- Primary DI / UDI-DI
- B195EE211 FDA UDI
- 510(k) Number
- K172312 FDA UDI
- FDA Product Code
- GWL FDA UDI
- GMDN Term
- Electroencephalographic signal amplifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1835 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Electroencephalographic signal amplifier
eego amplifier by eemagine Medical Imaging Solutions GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K172312 also covers:
- eego amplifier — eemagine Medical Imaging Solutions GmbH
- eego amplifier — eemagine Medical Imaging Solutions GmbH
- eego amplifier — eemagine Medical Imaging Solutions GmbH
- eego amplifier — eemagine Medical Imaging Solutions GmbH
- eego amplifier — eemagine Medical Imaging Solutions GmbH
- eego amplifier — eemagine Medical Imaging Solutions GmbH
- eego amplifier — eemagine Medical Imaging Solutions GmbH
- eego amplifier — eemagine Medical Imaging Solutions GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- eemagine Medical Imaging Solutions GmbH
Sources (2)
- FDA UDI a899b1bd-5d88-454a-b216-742dbcd839e7 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026