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Multi-frequency Linear-array Ultrasound Probe
EUDAMEDClass IIa (EU MDR)
Ref L5I50Model L8L38K, L7L38A, L7L38G, L8L38C, L7I38F, L5I50, L7I50, L7L50G, L8L50C, L8L50K, L10LC, L10LN
Identity
- Device Name
- Multi-frequency Linear-array Ultrasound Probe EUDAMED
- Model / Reference
- L8L38K, L7L38A, L7L38G, L8L38C, L7I38F, L5I50, L7I50, L7L50G, L8L50C, L8L50K, L10LC, L10LN EUDAMEDL5I50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938396403591 EUDAMED
- Basic UDI-DI
- 693839640010042879K00009E EUDAMED
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Multi-frequency Linear-array Ultrasound Probe by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 693839640010042879K00009E | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010834
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9bec4f18-03dd-4950-90b6-74d252719f85 61 fields · synced Oct 8, 2026