FDA.report

Technomed Europe

Primary DI
08718375863473
Brand
Technomed Europe
Company
Technomed Engineering B.V.
Model
TE/S50715-004
Device description
Disposable Subdermal Needle Electrode corkscrew 1.5m wire 4x6 colors 24pcs
Published
2019-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications

CodeDeviceSpecialtyClass
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08718375863473PackageGS124In Commercial Distribution
08718375861707PrimaryGS10

GMDN Terms

TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Device Sizes

TypeValueUnit
Length1.5Meter
Outer Diameter0.6Millimeter

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

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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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08720791378530CadwellTechnomed Engineering B.V.IKT2025-12-10
08720791378011CadwellTechnomed Engineering B.V.IKT2025-07-16
08720791378035CadwellTechnomed Engineering B.V.IKT2025-07-15
08720791375911CadwellTechnomed Engineering B.V.IKT2025-03-12
08054655008418Disposable EMG needle electrodesSPES MEDICA SPAIKT2025-03-03
08054655023350Disposable EMG needle electrodesSPES MEDICA SPAIKT2025-03-03
08720791376642CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791376680CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791376727CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791377861CadwellTechnomed Engineering B.V.IKT2025-01-16
08720791375232Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375256Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375355Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375379Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375393Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375416Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375478Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375515Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791377229Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377243Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377267Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377281Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377304Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377328Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377335CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377342CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377359CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377366CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377373CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377380CadwellTechnomed Engineering B.V.IKT2024-11-15