Identity
- Trade Name
- Phased array probe EUDAMEDUltrasound Probe EUDAMED
- Device Name
- Phased array probe EUDAMEDUltrasound Probe EUDAMED
- Model / Reference
- P2-5L19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972125711342 EUDAMED
- Basic UDI-DI
- 697212571B0049H EUDAMED
- Direct Marketing DI
- 06972125711342 EUDAMED
- EMDN Code
- Z110402010301 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL 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
Phased array probe by Dawei Medical (Jiangsu) Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697212571B0049H | 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 c76bc315-72ae-4ab8-ab40-aca2b52c5e6e 61 fields · synced Jun 19, 2026
- EUDAMED b8dbf67b-88f8-4c12-9c71-d8bc42c85ed0 61 fields · synced Jun 19, 2026