Technomed Europe

FDA UDI

Class II (US FDA UDI)

by Technomed Engineering B.V.

Identity

Trade Name: Technomed Europe FDA UDI
Generic Name: Subdermal needle electrode FDA UDI
Device Name: Disposable Subdermal Needle Electrode corkscrew, 2.0m wire, 4x6 colors, 24pcs with Protection Cap FDA UDI
Model / Reference: TE/S50715-002-C FDA UDI
Description: Disposable Subdermal Needle Electrode corkscrew, 2.0m wire, 4x6 colors, 24pcs with Protection Cap FDA UDI

Identifiers

Primary DI / UDI-DI: 08720791375294 FDA UDI
510(k) Number: K241045 FDA UDI
FDA Product Code: GXZ FDA UDI
IKT FDA UDI
GMDN Term: Subdermal needle electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
890.1385 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 2 Meter FDA UDI
Outer Diameter — 0.6 Millimeter FDA UDI
Needle Gauge — 23 Gauge FDA UDI

Category: Subdermal needle electrode

Technomed Europe by Technomed Engineering B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Subdermal needle electrode.

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Sphenoidal Electrode Set — Ad-Tech Medical Instrument Corp. · Class II
Spinal Electrode Kit — Ad-Tech Medical Instrument Corp. · Class II
Horizon™ — Advantage Medical Electronics, LLC · Class II
Neuroline SubdermalNeurology Needle Electrodes — Ambu A/S · Class II
Rhythmlink® — Rhythmlink International, LLC · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Technomed Engineering B.V.

Sources (1)

FDA UDI c9860a05-d561-4b0b-805e-c399ead6a2dc 36 fields · synced May 30, 2026