Identity
- Trade Name
- Color Doppler Ultrasound System EUDAMED
- Device Name
- Color Doppler Ultrasound System EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972174670003 EUDAMED
- Basic UDI-DI
- 697217467WEDCOLORULZG EUDAMED
- Direct Marketing DI
- 06972174670003 EUDAMED
- EMDN Code
- Z11040105 OBSTETRIC/GYNAECOLOGICAL 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
Color Doppler Ultrasound System by Shenzhen Well.d Medical Electronics 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 | 697217467WEDCOLORULZG | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Well.d Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000021303
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 31488888-5cee-46ce-af1d-374cc6553f65 61 fields · synced Jun 9, 2026