Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021192567

FEI Number

3021192567

Entity Name

PAMEL D.O.O.

City/State/Country

Zagreb Zagreb, Grad, HR

Establishment Address

Dubravica 41f, Zagreb Zagreb, Grad 10090, HR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pamel d.o.o. (Owner Number: 10083725)

Owner / Operator Contact Address

Dubravica 41f, Zagreb, HR-21 10090, HR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211315

PMA Number

N/A

All Registered Proprietary Names

COMBY EEG CAP ACCESSORIE COMBY EEG CAP EEG ELECTRODE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2021-12-14

Official Correspondent

Marko Pavic

US Agent Details

Bernhard Wandernoth Business: BEE Systems, Inc Email: prrc@bee.systems Phone: (818) 6481773

Related Public Records

Same Entity

Pamel d.o.o.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

Registration Number	Establishment Name	Location
3015614098	CGX, LLC	San Diego, CA, US
3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021192567. Last updated year: 2026. Please use registration number 3021192567 when referencing this establishment in official correspondence.