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 Hypodermic Needle Electrode, 0.75m leadwire, violet FDA UDI
Model / Reference: TE/L7570-335 FDA UDI
Description: Disposable Hypodermic Needle Electrode, 0.75m leadwire, violet FDA UDI

Identifiers

Primary DI / UDI-DI: 08720791377311 FDA UDI
FDA Product Code: IKT FDA UDI
GMDN Term: Electromyographic needle electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 75 Millimeter FDA UDI
Outer Diameter — 0.7 Millimeter FDA UDI
Needle Gauge — 22 Gauge 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

Similar devices

Also classified as Electromyographic needle electrode, single-use.

The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC. · Class II
Bio Protech — BIO PROTECH USA, INC. · Class II
MediMax Tech — MEDIMAX TECH INC. · Class II
Dragonfly® — NEUROVISION MEDICAL PRODUCTS, INC. · Class II
Cobra® — NEUROVISION MEDICAL PRODUCTS, INC. · Class II
Neuroline InojectNeurology Needle Electrodes — Ambu A/S · Class II
NATUS NEUROLOGY — Natus Neurology Incorporated · Class II
BIONEN — BIONEN SAS DI BARBARA NENCIONI & C. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Technomed Engineering B.V.

Sources (1)

FDA UDI 25799b53-f530-4165-97b3-9cd2a7222fe9 35 fields · synced Jun 7, 2026