FDA.reportPublic FDA data

COMBY EEG CAP

Primary DI
03858894154500
Brand
COMBY EEG CAP
Company
PAMEL d.o.o.
Model
Chest belt for EEG cap for adults, L
Catalog number
BFRA_L
Device description
Chest belt for EEG cap for adults, size L
Published
2025-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211315000Comby EEG CapsPamel D.O.O2021-11-09GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03858894154500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03858894154500038588941545003858894154500

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, reusableA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk/star with a conductive surface (e.g., tin, gold, silver, titanium, conductive plastic) and may include a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from direct sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
643949162
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03858894154517COMBY EEG CAPChest belt for EEG cap for adults, MBFRA_M2025-02-28
03858894154524COMBY EEG CAPChest belt for EEG cap for adults, SBFRA_S2025-02-28
03858894152810COMBY EEG CAPComby EEG Cap/ 34 Ag/AgCl EL. CEC13447522023-08-16
03858894152827COMBY EEG CAPComby EEG Cap/ 34 Ag/AgCl EL. CEC13452572023-08-16
03858894152834COMBY EEG CAPComby EEG Cap/ 34 Ag/AgCl EL. CEC13457622023-08-16
03858894153398COMBY EEG CAPBypass electrodes Ag/AgClBYP102023-08-16
03858894153411COMBY EEG CAPBypass electrodes Ag/AgCl, greenBYP10G2023-08-16
03858894153428COMBY EEG CAPBypass electrodes Ag/AgCl, redBYP10R2023-08-16
03858894153442COMBY EEG CAPBypass electrodes Ag/AgCl, yellowBYP10Y2023-08-16
03858894154135COMBY EEG CAPChest belt for EEG cap for adultsBFRA2023-08-16
03858894153183COMBY EEG CAPELECUP120 - CUP Ag/AgCl electrodeELECUP5SET1202022-08-16
03858894151950COMBY EEG CAPComby EEG Cap/ 22 Ag/AgCl EL. CEC12247522022-08-16
03858894151967COMBY EEG CAPComby EEG Cap/ 22 Ag/AgCl EL. CEC12252572022-08-16
03858894151974Comby EEG CapComby EEG Cap/ 22 Ag/AgCl EL. CEC12257622022-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
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