Identity
- Trade Name
- Leltek EUDAMED
- Device Name
- Diagnostic Ultrasound Imaging System EUDAMED
- Model / Reference
- LU700C/LU700L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14719882150057 EUDAMED
- Basic UDI-DI
- 40761LU700L9 EUDAMED
- Direct Marketing DI
- 14719882150057 EUDAMED
- EMDN Code
- Z11040106 HANDHELD ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Leltek by Leltek Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40761LU700L9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Leltek Inc.
- EUDAMED SRN
- TW-MF-000013923
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 113003e5-0d45-4dce-b56f-34f3a1e74698 61 fields · synced May 23, 2026