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Diagnostic Ultrasound Device
EUDAMEDClass IIa (EU MDR)
Ref DW-F9Model 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-F3Ref DW-L30Model DW-L90, DW-L80, DW-L60, DW-L50, DW-L30, DW-L9, DW-L8, DW-L6, DW-L5, DW-L3Ref DW-F3Ref DW-L50Ref DW-L9Ref DW-P50Model DW-P90, DW-P80, DW-P60, DW-P50, DW-P30, DW-P9, DW-P8, DW-P6, DW-P5, DW-P3Ref DW-L8Ref DW-F80Ref DW-L80Ref DW-F90Ref DW-P9Ref DW-L90Ref DW-P3Ref DW-L5Ref DW-T30Ref DW-L60Ref DW-T9Ref DW-F30Ref DW-L3Ref DW-P30Ref DW-F8Ref DW-P60Ref DW-T60Ref DW-F60Ref DW-T90
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-F9 EUDAMEDDW-L90, DW-L80, DW-L60, DW-L50, DW-L30, DW-L9, DW-L8, DW-L6, DW-L5, DW-L3 EUDAMEDDW-L30 EUDAMEDDW-F3 EUDAMEDDW-L50 EUDAMEDDW-L9 EUDAMEDDW-P90, DW-P80, DW-P60, DW-P50, DW-P30, DW-P9, DW-P8, DW-P6, DW-P5, DW-P3 EUDAMEDDW-P50 EUDAMEDDW-L8 EUDAMEDDW-F80 EUDAMEDDW-L80 EUDAMEDDW-F90 EUDAMEDDW-P9 EUDAMEDDW-L90 EUDAMEDDW-P3 EUDAMEDDW-L5 EUDAMEDDW-T30 EUDAMEDDW-L60 EUDAMEDDW-T9 EUDAMEDDW-F30 EUDAMEDDW-L3 EUDAMEDDW-P30 EUDAMEDDW-F8 EUDAMEDDW-P60 EUDAMEDDW-T60 EUDAMEDDW-F60 EUDAMEDDW-T90 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972125710826 EUDAMED06972125711014 EUDAMED06972125710864 EUDAMED06972125711007 EUDAMED06972125711021 EUDAMED06972125710901 EUDAMED06972125711038 EUDAMED06972125710789 EUDAMED06972125710987 EUDAMED06972125710772 EUDAMED06972125710925 EUDAMED06972125710970 EUDAMED06972125710963 EUDAMED06972125711052 EUDAMED06972125710710 EUDAMED06972125710994 EUDAMED06972125710727 EUDAMED06972125710819 EUDAMED06972125711069 EUDAMED06972125710918 EUDAMED06972125710833 EUDAMED06972125710895 EUDAMED06972125710697 EUDAMED06972125710796 EUDAMED06972125710673 EUDAMED
- Basic UDI-DI
- 697212571A00194 EUDAMED697212571A00398 EUDAMED697212571A00296 EUDAMED
- Direct Marketing DI
- 06972125710826 EUDAMED06972125711014 EUDAMED06972125710864 EUDAMED06972125711007 EUDAMED06972125711021 EUDAMED06972125710901 EUDAMED06972125711038 EUDAMED06972125710789 EUDAMED06972125710987 EUDAMED06972125710772 EUDAMED06972125710925 EUDAMED06972125710970 EUDAMED06972125710963 EUDAMED06972125711052 EUDAMED06972125710710 EUDAMED06972125710994 EUDAMED06972125710727 EUDAMED06972125710819 EUDAMED06972125711069 EUDAMED06972125710918 EUDAMED06972125710833 EUDAMED06972125710895 EUDAMED06972125710697 EUDAMED06972125710796 EUDAMED06972125710673 EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMEDZ11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDTürkiye EUDAMEDSpain EUDAMEDGreece EUDAMEDGermany EUDAMEDFrance 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 (25)
- EUDAMED 98b1c1d9-1bc8-4fba-a426-280c40780fbd 61 fields · synced Sep 17, 2026
- EUDAMED 9cc7bfa9-57a3-490e-a172-d923bd383f07 61 fields · synced May 16, 2026
- EUDAMED 1f30d5a7-1d2a-47bc-9f16-5e4ce6b7bd43 61 fields · synced May 16, 2026
- EUDAMED e18444cd-d2e1-477a-a68b-f89c83fbf7fa 61 fields · synced May 16, 2026
- EUDAMED bffbaa32-5b46-4690-b350-3e3d50c83c9a 61 fields · synced May 17, 2026
- EUDAMED 088710cc-b9d7-4c16-abda-7299313c61e3 61 fields · synced May 17, 2026
- EUDAMED 0c25e4be-9f32-48b3-becf-6b419afdc340 61 fields · synced May 17, 2026
- EUDAMED daced37d-7559-404d-a2eb-7f4ce081e6f1 61 fields · synced May 17, 2026
- EUDAMED f8be0084-fdfc-4ced-8dd8-aea269c35056 61 fields · synced May 17, 2026
- EUDAMED c991bc23-a527-462a-920b-473e0d73a5ac 61 fields · synced May 17, 2026
- EUDAMED 1d09453e-7cd3-4d72-96f2-b263c13b067d 61 fields · synced May 17, 2026
- EUDAMED 70775de2-41fb-4bd1-b4da-637b637f878c 61 fields · synced May 17, 2026
- EUDAMED 42279cd3-bdae-47e0-97bc-a85c4940bbea 61 fields · synced May 18, 2026
- EUDAMED 6ef69dfa-0c6d-46d3-9fd4-c174b377a90a 61 fields · synced May 18, 2026
- EUDAMED 800a2caa-3ba7-4503-b192-1b22944b62c0 61 fields · synced May 18, 2026
- EUDAMED c56f9ee4-7d98-4e67-a606-292d721f2892 61 fields · synced May 18, 2026
- EUDAMED 74b9c173-cda2-46ed-a713-1dd511042a0f 61 fields · synced May 18, 2026
- EUDAMED eae190ba-f81f-4502-91d7-c2010a4a5a98 61 fields · synced May 18, 2026
- EUDAMED dd8d174f-05c1-4083-be34-43d14e9aebf5 61 fields · synced May 18, 2026
- EUDAMED d785027d-0539-4376-a7b9-e63f1f3705e3 61 fields · synced May 18, 2026
- EUDAMED dc6c03d4-2818-4a24-bcb9-4d968c6889a6 61 fields · synced May 18, 2026
- EUDAMED 8affdce0-022f-4c18-82ed-9d523b9e2634 61 fields · synced May 18, 2026
- EUDAMED 4953032c-5529-4245-ba59-12f0229d1ca2 61 fields · synced May 18, 2026
- EUDAMED 50ac3475-a956-4232-925d-f8666d96eceb 61 fields · synced May 19, 2026
- EUDAMED 956843d1-7a57-492f-9da6-e0f6fac5f83d 61 fields · synced May 19, 2026