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Multi-frequency Phased-array Ultrasound Probe
EUDAMEDClass IIa (EU MDR)
Ref TR5-14Model P3F14K、P3F14C、P5FN、TR2-14、TR5-14
Identity
- Device Name
- Multi-frequency Phased-array Ultrasound Probe EUDAMED
- Model / Reference
- P3F14K、P3F14C、P5FN、TR2-14、TR5-14 EUDAMEDTR5-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938396496012 EUDAMED
- Basic UDI-DI
- 693839640010042897K00009N 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 Phased-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 | 693839640010042897K00009N | 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 cf68f22f-64c4-459e-9e72-695400f333c1 61 fields · synced Oct 9, 2026