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Endovascular Laser Vein System (ELVeS®) Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 501300366Ref 501803150Ref 501100150Ref 501100100Ref 501100145Ref 501803170Ref 503100142Ref 503803150Ref 501300365Ref 503100100Ref 503100170Ref 501100140Ref 503100155Ref 502300330
Identity
- Trade Name
- Endovascular Laser Vein System (ELVeS®) Kit FDA UDI
- Generic Name
- Varicose vein lasing procedure kit FDA UDI
- Device Name
- ELVeS® EUDAMED
- Model / Reference
- 501300366 EUDAMED501803150 EUDAMED501100150 EUDAMED501100100 EUDAMED501100145 EUDAMED501803170 EUDAMED503100142 EUDAMED503803150 EUDAMED501300365 EUDAMED503100100 EUDAMED503100170 EUDAMED501100140 EUDAMED503100155 EUDAMED502300330 EUDAMEDELVeS® Radial® Slim Kit 4Fx7cm FDA UDI
Identifiers
- Catalog Number
- 101230 FDA UDI
- Primary DI / UDI-DI
- 04049089003683 EUDAMED04049089003553 EUDAMED04049089003515 EUDAMED04049089003478 EUDAMED04049089003508 EUDAMED04049089003560 EUDAMED04049089003591 EUDAMED04049089003652 EUDAMED04049089003676 EUDAMED04049089003577 EUDAMED04049089003638 EUDAMED04049089003485 EUDAMED04049089003621 EUDAMED04049089003690 EUDAMED04049089100276 FDA UDI
- Basic UDI-DI
- 404908901NM EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Varicose vein lasing procedure kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Latvia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Varicose vein lasing procedure kit
Endovascular Laser Vein System (ELVeS®) Kit by Ceram Optec SIA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Varicose vein lasing procedure kit.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ceram Optec SIA
Sources (15)
- FDA UDI f7f6c9a1-863b-4bf0-886c-0cdbb323528e 33 fields · synced Aug 5, 2026
- EUDAMED a269264a-bc50-4deb-87fc-42c02e7f8014 61 fields · synced Jul 8, 2026
- EUDAMED e88304fa-2615-4064-8fe8-34033fd44fd9 61 fields · synced Jul 9, 2026
- EUDAMED 8809c396-8b29-4ea0-b3f1-1323dc02d578 61 fields · synced Jul 10, 2026
- EUDAMED a58d477c-217f-4b29-8af1-3e79f8af5376 61 fields · synced Jul 11, 2026
- EUDAMED 3f56eb3d-d3fe-489c-a28e-43e503a0ced0 61 fields · synced Jul 13, 2026
- EUDAMED ae8b2225-217e-48b2-b4a7-7e33e24bd610 61 fields · synced Jul 14, 2026
- EUDAMED 38eb4212-847c-4b75-a4b2-6629fa823f6f 61 fields · synced Jul 15, 2026
- EUDAMED 3ff3113b-7c12-49b9-922f-f150002bea6c 61 fields · synced Jul 19, 2026
- EUDAMED 1e415a95-121f-4062-acff-7f1d9040477c 61 fields · synced Jul 22, 2026
- EUDAMED 73f23da2-3616-42b0-86df-fb484119cb9b 61 fields · synced Jul 26, 2026
- EUDAMED 92e84fb7-f56b-4017-9b07-bdbbfd5b33e2 61 fields · synced Jul 27, 2026
- EUDAMED cbd6e013-cbaa-42df-93e3-6e3fe981bd0b 61 fields · synced Jul 31, 2026
- EUDAMED 2c4ff35c-405f-4d9c-b584-c8f99601932f 61 fields · synced Aug 4, 2026
- EUDAMED 71d724ee-fd48-4888-a154-7b0d0b131a84 61 fields · synced Aug 5, 2026