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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
Analytical scalp electrode, reusable FDA UDI
Device Name
Bypass electrodes Ag/AgCl, yellow FDA UDI
Model / Reference
Bypass electrodes Ag/AgCl, yellow FDA UDI
Description
Bypass electrodes Ag/AgCl, yellow FDA UDI

Identifiers

Catalog Number
BYP10Y FDA UDI
Primary DI / UDI-DI
03858894153442 FDA UDI
510(k) Number
K211315 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Analytical scalp electrode, 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Analytical scalp electrode, 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 Analytical scalp electrode, 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 a85c2ccf-7cfe-4d70-b840-85b49e117223 36 fields · synced Jun 6, 2026