Identity
- Trade Name
- Linear probe EUDAMEDUltrasound Probe EUDAMED
- Device Name
- Linear probe EUDAMEDUltrasound Probe EUDAMED
- Model / Reference
- L5-12L46 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972125711335 EUDAMED
- Basic UDI-DI
- 697212571B0039F EUDAMED
- Direct Marketing DI
- 06972125711335 EUDAMED
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Linear probe by Dawei Medical (Jiangsu) 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 | 697212571B0039F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dawei Medical (Jiangsu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025846
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 9285ac64-7f16-4cbc-8907-b17d57a224fc 61 fields · synced Jul 25, 2026
- EUDAMED 0fcd2f43-a2c0-4434-a964-e97288c2e6e4 61 fields · synced Jul 25, 2026