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waveguard

FDA UDI

Class II (US FDA UDI)

by eemagine Medical Imaging Solutions GmbH

Identity

Trade Name
waveguard FDA UDI
Generic Name
Electroencephalographic electrode cap, reusable FDA UDI
Device Name
eeg cap FDA UDI
Model / Reference
CA-191 FDA UDI
Description
eeg cap FDA UDI

Identifiers

Primary DI / UDI-DI
B195CA191 FDA UDI
510(k) Number
K110223 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Electroencephalographic electrode cap, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 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

Category: Electroencephalographic electrode cap, reusable

waveguard by eemagine Medical Imaging Solutions GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalographic electrode cap, reusable.

Cleared under the same submission

K110223 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
eemagine Medical Imaging Solutions GmbH

Sources (1)

  • FDA UDI e1a9b9b1-f3e7-442b-857d-25f29d56b544 35 fields · synced Jun 6, 2026