Technomed Europe

FDA UDI

Class II (US FDA UDI)

by Technomed Engineering B.V.

Identity

Trade Name: Technomed Europe FDA UDI
Generic Name: Electromyographic needle electrode, single-use FDA UDI
Device Name: Disposable Subdermal Needle Electrode corkscrew 2.0m twisted wire 12pairs FDA UDI
Model / Reference: TE/S50725-002 FDA UDI
Description: Disposable Subdermal Needle Electrode corkscrew 2.0m twisted wire 12pairs FDA UDI

Identifiers

Primary DI / UDI-DI: 08720791375430 FDA UDI
510(k) Number: K241045 FDA UDI
FDA Product Code: GXZ FDA UDI
IKT FDA UDI
GMDN Term: Electromyographic needle electrode, single-use 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: Outer Diameter — 0.60 Millimeter FDA UDI
Length — 2 Meter FDA UDI

Category: Electromyographic needle electrode, single-use

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

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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 734bd07a-0870-4c03-bb14-a064dda06b1f 36 fields · synced Jun 1, 2026