Swaromed

FDA UDI

Class II (US FDA UDI)

by TYROLMED GmbH

Identity

Trade Name: SWAROMED FDA UDI
Generic Name: Electrocardiographic electrode, single-use FDA UDI
Device Name: ECG Electrodes FDA UDI
Model / Reference: 4107 FDA UDI
Description: ECG Electrodes FDA UDI

Identifiers

Catalog Number: 6001377N FDA UDI
Primary DI / UDI-DI: 19120026222830 FDA UDI
FDA Product Code: DRX FDA UDI
GMDN Term: Electrocardiographic electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiographic electrode, single-use

Swaromed by TYROLMED GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: TYROLMED GmbH

Sources (1)

FDA UDI 6c4dd5c9-48ec-4068-9439-bde2bc74bf7e 35 fields · synced Jun 6, 2026