FDA.report

Technomed Europe

Primary DI
08718375869727
Brand
Technomed Europe
Company
Technomed Engineering B.V.
Model
TE/C55-632
Device description
Disposable XS Cup Electrode Ag/AgCl, 10 pieces
Published
2022-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08718375869727PrimaryGS10

GMDN Terms

TermDefinition
Analytical scalp electrode, single-useA 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 with a conductive surface (e.g., tin, gold, conductive plastic) and 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 single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Device Sizes

TypeValueUnit
Length1.5Meter
Outer Diameter6Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+31434086868info@technomed.nl

Regulatory Flags

DUNS number
418415568
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08720791377700Inomed5256202025-12-10
08720791377717Inomed5256212025-12-10
08720791377724Inomed5256222025-12-10
08720791377731Inomed5256232025-12-10
08720791377847Inomed5200482025-12-10
08720791378530Cadwell302882-0002025-12-10
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08720791378592Technomed EuropeTE/C53-4382025-11-11
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08720791378615Technomed EuropeTE/C53-8382025-11-11
08720791378622Technomed EuropeTE/C53-9382025-11-11
08720791378011Cadwell302862-000-GP22025-07-16
08720791378035Cadwell302864-000-GP22025-07-15
08720791377656Cadwell302906-0002025-05-26
08720791377670Cadwell302907-0002025-05-26
08720791375911Cadwell302881-0002025-03-12
08720791374587Neurosign4000-002025-02-28

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