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Diagnostic Ultrasound Device
EUDAMEDClass IIa (EU MDR)
Ref DW-P90Model DW-P90, DW-P80, DW-P60, DW-P50, DW-P30, DW-P9, DW-P8, DW-P6, DW-P5, DW-P3
Identity
- Trade Name
- Diagnostic Ultrasound Device EUDAMED
- Device Name
- Diagnostic Ultrasound Device EUDAMED
- Model / Reference
- DW-P90, DW-P80, DW-P60, DW-P50, DW-P30, DW-P9, DW-P8, DW-P6, DW-P5, DW-P3 EUDAMEDDW-P90 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972125710871 EUDAMED
- Basic UDI-DI
- 697212571A00296 EUDAMED
- Direct Marketing DI
- 06972125710871 EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Diagnostic Ultrasound Device 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 | 697212571A00296 | 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 (1)
- EUDAMED 561e277c-4596-4d2c-9ee4-e4eaee243c1e 61 fields · synced Jun 18, 2026