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Multi-frequency 4D Ultrasound Probe
EUDAMEDClass IIa (EU MDR)
Ref 4DL40KModel 4DL40K, C5LN, 4DL40A, 4DL40G, C5L40CRef 4DL40A
Identity
- Device Name
- Multi-frequency 4D Ultrasound Probe EUDAMED
- Model / Reference
- 4DL40K, C5LN, 4DL40A, 4DL40G, C5L40C EUDAMED4DL40K EUDAMED4DL40A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938396495039 EUDAMED06938396495015 EUDAMED
- Basic UDI-DI
- 693839640010042846K00006L 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 4D 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 | 693839640010042846K00006L | 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 (2)
- EUDAMED f4f26b53-e862-4aef-a0e9-10ab0ff5290f 61 fields · synced Oct 6, 2026
- EUDAMED dec5731a-4953-46d3-a7ed-a5c7409988af 61 fields · synced May 17, 2026