Endovascular Laser Vein System (ELVeS®) Kit

FDA UDI

Class II (US FDA UDI)

by Ceram Optec SIA

Identity

Trade Name: Endovascular Laser Vein System (ELVeS®) Kit FDA UDI
Generic Name: Varicose vein lasing procedure kit FDA UDI
Model / Reference: ELVeS® Radial® Kit 6Fx11cm FDA UDI

Identifiers

Catalog Number: 101030 FDA UDI
Primary DI / UDI-DI: 04049089100269 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Varicose vein lasing procedure kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 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

Yes

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

Category: Varicose vein lasing procedure kit

Endovascular Laser Vein System (ELVeS®) Kit by Ceram Optec SIA — 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: Ceram Optec SIA

Sources (1)

FDA UDI b70c60ed-3b8f-4166-9878-3f374df379b5 33 fields · synced May 30, 2026