Identity
- Device Name
- Ultrasound Probes EUDAMED
- Model / Reference
- UC5-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973914210060 EUDAMED
- Basic UDI-DI
- 697391421UC52LB EUDAMED
- Direct Marketing DI
- 06973914210060 EUDAMED
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Category: Extracorporeal ultrasound imaging transducer, hand-held
Ultrasound Probes by Beijing iTrason Technologies Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697391421UC52LB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing iTrason Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000032285
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED a84ca3b1-80d9-4c0f-824e-5aea1e6a230d 61 fields · synced Jun 19, 2026