FDA.reportPublic FDA data

COMBY EEG CAP

Primary DI
03858894152827
Brand
COMBY EEG CAP
Company
PAMEL d.o.o.
Model
Comby EEG Cap/ 34 Ag/AgCl EL.
Catalog number
CEC1345257
Device description
Comby EEG cap with 34 Ag/AgCl sintered electrodes, size 52-57
Published
2023-08-16
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
03858894152827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03858894152827038588941528273858894152827

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic electrode cap, reusableAn array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap with integrated (and often removable) scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. 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
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03858894154500COMBY EEG CAPChest belt for EEG cap for adults, LBFRA_L2025-02-28
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
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
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
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
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08