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Diagnostic Ultrasound Device
EUDAMEDClass IIa (EU MDR)
Ref DW-T6Model DW-T90, DW-T80, DW-T60, DW-T50, DW-T30, DW-T9, DW-T8, DW-T6, DW-T5, DW-T3, DW-F90, DW-F80, DW-F60, DW-F50, DW-F30, DW-F9, DW-F8, DW-F6, DW-F5, DW-F3
Identity
- Trade Name
- Diagnostic Ultrasound Device EUDAMED
- Device Name
- Diagnostic Ultrasound Device EUDAMED
- Model / Reference
- DW-T90, DW-T80, DW-T60, DW-T50, DW-T30, DW-T9, DW-T8, DW-T6, DW-T5, DW-T3, DW-F90, DW-F80, DW-F60, DW-F50, DW-F30, DW-F9, DW-F8, DW-F6, DW-F5, DW-F3 EUDAMEDDW-T6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972125710741 EUDAMED
- Basic UDI-DI
- 697212571A00194 EUDAMED
- Direct Marketing DI
- 06972125710741 EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) 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
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 | 697212571A00194 | 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 6f1e6f70-19a3-4602-bbca-f061e9480519 61 fields · synced Jun 18, 2026