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; 2.5m wire FDA UDI
Model / Reference: TE/S49-938 FDA UDI
Description: Disposable Subdermal Needle Electrode; 2.5m wire FDA UDI

Identifiers

Primary DI / UDI-DI: 08718375863602 FDA UDI
FDA Product Code: IKT FDA UDI
GXZ FDA UDI
GMDN Term: Subdermal needle electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1385 FDA UDI
882.1350 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: Needle Gauge — 26 Gauge FDA UDI
Outer Diameter — 0.45 Millimeter FDA UDI
Length — 19 Millimeter 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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Rhythmlink® — Rhythmlink International, LLC · 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

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Manufacturer

Manufacturer: Technomed Engineering B.V.

Sources (1)

FDA UDI d396d2d9-d3ef-460e-9d35-f5e47fd471f2 35 fields · synced May 30, 2026