FDA.report

Technomed Europe

Primary DI
08718375868027
Brand
Technomed Europe
Company
Technomed Engineering B.V.
Model
TE/K50433-015
Device description
Disposable Adhesive Surface Electrodes, 4-disk, 1.5m twisted wire, 8 sets
Published
2021-10-04
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

Contact Domains

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08718375868027PackageGS18In Commercial Distribution
08718375868034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08718375868027087183758680278718375868027
08718375868034087183758680348718375868034

GMDN Terms

TermDefinition
Analytical non-scalp cutaneous electrodeA non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. 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 Diameter20Millimeter

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08720791377700Inomed5256202025-12-10
08720791377717Inomed5256212025-12-10
08720791377724Inomed5256222025-12-10
08720791377731Inomed5256232025-12-10
08720791377847Inomed5200482025-12-10
08720791378530Cadwell302882-0002025-12-10
08720791378554Technomed EuropeTE/C52-4382025-11-11
08720791378561Technomed EuropeTE/C52-6382025-11-11
08720791378578Technomed EuropeTE/C52-8382025-11-11
08720791378585Technomed EuropeTE/C52-9382025-11-11
08720791378592Technomed EuropeTE/C53-4382025-11-11
08720791378608Technomed EuropeTE/C53-6382025-11-11
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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