← Back to catalogue
Echolaser Smart Interface (ESI)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref EI KT0 0005 020
by Elesta Spa
Identity
- Trade Name
- ECHOLASER SMART INTERFACE EUDAMEDEcholaser Smart Interface (ESI) FDA UDI
- Generic Name
- Ultrasound-guided laser thermal therapy needle guide positioning system FDA UDI
- Device Name
- ECHOLASER SMART INTERFACE EUDAMEDEcholaser Smart Interface (ESI) and its accessories FDA UDI
- Model / Reference
- EI KT0 0005 020 EUDAMEDEI KT0 0005 521 FDA UDI
- Description
- Echolaser Smart Interface (ESI) and its accessories FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08052286590173 EUDAMEDFDA UDI
- Basic UDI-DI
- 805228659EIKT00005xxx62 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Ultrasound-guided laser thermal therapy needle guide positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasound-guided laser thermal therapy needle guide positioning system
Echolaser Smart Interface (ESI) by Elesta Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elesta Spa
Sources (2)
- FDA UDI 0d93beaa-edf2-4213-abc7-378d2e3e7a7d 33 fields · synced Jun 11, 2026
- EUDAMED 9c8df25c-95ab-4d7c-b08a-a7fef84939b4 61 fields · synced Jun 11, 2026