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Wireless Diagnostic Ultrasound Device
EUDAMEDClass IIa (EU MDR)
Ref DW-C1SModel DW-C1, DW-C2, DW-C1S, DW-C2S
Identity
- Trade Name
- Wireless Diagnostic Ultrasound Device EUDAMED
- Device Name
- Wireless Diagnostic Ultrasound Device EUDAMED
- Model / Reference
- DW-C1, DW-C2, DW-C1S, DW-C2S EUDAMEDDW-C1S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972125711625 EUDAMED
- Basic UDI-DI
- 697212571A0059C EUDAMED
- EMDN Code
- Z11040106 HANDHELD ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Wireless 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 | 697212571A0059C | 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 29517b9d-94d0-4fbe-a6e7-8bb7d876d934 61 fields · synced Jun 17, 2026