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Wireless Diagnostic Ultrasound Device
EUDAMEDClass IIa (EU MDR)
Ref DW-C2Model DW-C1, DW-C2, DW-C1S, DW-C2SRef DW-X1Model DW-X1, DW-X2, DW-X1S, DW-X2SRef DW-L2Model DW-L1, DW-L2, DW-L1S, DW-L2SRef DW-C2SRef DW-L1Ref DW-X2S
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-C2 EUDAMEDDW-X1, DW-X2, DW-X1S, DW-X2S EUDAMEDDW-X1 EUDAMEDDW-L1, DW-L2, DW-L1S, DW-L2S EUDAMEDDW-L2 EUDAMEDDW-C2S EUDAMEDDW-L1 EUDAMEDDW-X2S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972125711632 EUDAMED06972125711601 EUDAMED06972125711670 EUDAMED06972125711649 EUDAMED06972125711656 EUDAMED06972125711595 EUDAMED
- Basic UDI-DI
- 697212571A0059C EUDAMED697212571A0049A EUDAMED697212571A0069E EUDAMED
- EMDN Code
- Z11040106 HANDHELD ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMEDIreland EUDAMEDPoland 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 (6)
- EUDAMED eec80528-8cdb-48c5-a965-f5585a45547b 61 fields · synced Sep 18, 2026
- EUDAMED 7875f6dd-bcf7-4c81-8ce0-9dfc1d1dfbe8 61 fields · synced May 17, 2026
- EUDAMED 933b5cee-b6a5-4b04-a345-0caa95501942 61 fields · synced May 17, 2026
- EUDAMED 0e45f751-db08-4223-bd0e-ba0d91fec0bd 61 fields · synced May 17, 2026
- EUDAMED b175f757-423a-40de-89b8-a6ac50ad81c7 61 fields · synced May 18, 2026
- EUDAMED de738382-97f7-4dfe-9a72-cbc0c4e43c20 61 fields · synced May 18, 2026