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Ultrasound Probes
EUDAMEDClass IIa (EU MDR)
Ref 7L4Ref UL10-5Ref UL10-5SRef 2P2
Identity
- Device Name
- Ultrasound Probes EUDAMED
- Model / Reference
- 7L4 EUDAMEDUL10-5 EUDAMEDUL10-5S EUDAMED2P2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973914210107 EUDAMED06973914210046 EUDAMED06973914210053 EUDAMED06973914210138 EUDAMED
- Basic UDI-DI
- 6973914217L4NS EUDAMED697391421UL105JQ EUDAMED697391421UL105SJ5 EUDAMED6973914212P2N9 EUDAMED
- Direct Marketing DI
- 06973914210107 EUDAMED06973914210046 EUDAMED06973914210053 EUDAMED06973914210138 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 | 6973914217L4NS | 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 (4)
- EUDAMED bbd4f961-f47f-4bfb-bd1c-694c9abec918 61 fields · synced Aug 2, 2026
- EUDAMED 8ba1070c-9cc8-4afe-a821-c3f68ade2163 61 fields · synced May 18, 2026
- EUDAMED 35fdc687-f3ff-48a6-8ee5-548587d4eae6 61 fields · synced May 18, 2026
- EUDAMED 6ad2f94f-f911-4130-8af5-d7fd3a9505be 61 fields · synced May 18, 2026