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Comby Eeg Cap

FDA UDI

Class II (US FDA UDI)

by PAMEL d.o.o.

Identity

Trade Name
COMBY EEG CAP FDA UDI
Generic Name
Electroencephalographic electrode cap, reusable FDA UDI
Device Name
Comby EEG cap with 34 Ag/AgCl sintered electrodes, size 52-57 FDA UDI
Model / Reference
Comby EEG Cap/ 34 Ag/AgCl EL. FDA UDI
Description
Comby EEG cap with 34 Ag/AgCl sintered electrodes, size 52-57 FDA UDI

Identifiers

Catalog Number
CEC1345257 FDA UDI
Primary DI / UDI-DI
03858894152827 FDA UDI
510(k) Number
K211315 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electroencephalographic electrode cap, reusable

Comby Eeg Cap by PAMEL d.o.o. — 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

K211315 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PAMEL d.o.o.

Sources (1)

  • FDA UDI 266d5004-f944-48a7-b9fc-44213dc6788a 36 fields · synced May 30, 2026