Identity
- Trade Name
- 4D volume probe EUDAMEDUltrasound Probe EUDAMED
- Device Name
- 4D volume probe EUDAMEDUltrasound Probe EUDAMED
- Model / Reference
- R40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972125711359 EUDAMED
- Basic UDI-DI
- 697212571B0059K EUDAMED
- Direct Marketing DI
- 06972125711359 EUDAMED
- EMDN Code
- Z110402010202 CURVILINEAR TRANSCUTANEOUS MULTIDIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
4D volume 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 | 697212571B0059K | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dawei Medical (Jiangsu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025846
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED fa03076d-3956-4b68-92f1-95cfae445ebc 61 fields · synced Jul 11, 2026
- EUDAMED 283203b5-26e4-48c6-b194-3dd2ff7bac43 61 fields · synced Jul 11, 2026