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Diagnostic Ultrasound System
EUDAMEDClass IIa (EU MDR)
Ref Rocvue T6 ActiveModel Rocvue T seriesRef Rocvue T3 ActiveRef WE9IModel WE seriesRef SE7PRef WE9Ref SE9Ref Rocvue H5Model Rocvue H seriesRef Rocvue T7 ProRef Rocvue T6Ref Rocvue T5IRef Rocvue T5 SuperRef WE8PRef Rocvue T3Ref Rocvue H6 PlusRef Rocvue T7Ref WE8Ref Rocvue T9Ref Rocvue T9 PlusRef Rocvue T7 PlusRef Rocvue T5 PlusRef Rocvue T7IRef Rocvue T6 PlusRef Rocvue H7 PlusRef Rocvue T5Ref WE9PRef WE8CVRef WE9CVRef WE8IRef Rocvue T5 Pro
Identity
- Device Name
- Diagnostic Ultrasound System EUDAMED
- Model / Reference
- Rocvue T series EUDAMEDRocvue T6 Active EUDAMEDRocvue T3 Active EUDAMEDWE series EUDAMEDWE9I EUDAMEDSE7P EUDAMEDWE9 EUDAMEDSE9 EUDAMEDRocvue H series EUDAMEDRocvue H5 EUDAMEDRocvue T7 Pro EUDAMEDRocvue T6 EUDAMEDRocvue T5I EUDAMEDRocvue T5 Super EUDAMEDWE8P EUDAMEDRocvue T3 EUDAMEDRocvue H6 Plus EUDAMEDRocvue T7 EUDAMEDWE8 EUDAMEDRocvue T9 EUDAMEDRocvue T9 Plus EUDAMEDRocvue T7 Plus EUDAMEDRocvue T5 Plus EUDAMEDRocvue T7I EUDAMEDRocvue T6 Plus EUDAMEDRocvue H7 Plus EUDAMEDRocvue T5 EUDAMEDWE9P EUDAMEDWE8CV EUDAMEDWE9CV EUDAMEDWE8I EUDAMEDRocvue T5 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975329590744 EUDAMED06975329590843 EUDAMED06975329590317 EUDAMED06975329590546 EUDAMED06975329590300 EUDAMED06975329590553 EUDAMED06975329590010 EUDAMED06975329590270 EUDAMED06975329590690 EUDAMED06975329590782 EUDAMED06975329590775 EUDAMED06975329590379 EUDAMED06975329590812 EUDAMED06975329590041 EUDAMED06975329590232 EUDAMED06975329590348 EUDAMED06975329590614 EUDAMED06975329590621 EUDAMED06975329590256 EUDAMED06975329590768 EUDAMED06975329590263 EUDAMED06975329590706 EUDAMED06975329590065 EUDAMED06975329590751 EUDAMED06975329590331 EUDAMED06975329590362 EUDAMED06975329590324 EUDAMED06975329590355 EUDAMED06975329590799 EUDAMED
- Basic UDI-DI
- 697532959A012000152 EUDAMED697532959A021000154 EUDAMED697532959A01100014P 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
- Netherlands 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 System by Shenzhen Krinwave Technology 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 | 697532959A012000152 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Krinwave Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032042
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (29)
- EUDAMED be294379-fc7c-45ad-84f6-6d0fb96eaaa5 61 fields · synced Sep 17, 2026
- EUDAMED fc917839-7d47-4dba-ab18-8da91586d62f 61 fields · synced May 11, 2026
- EUDAMED c6fa7358-14d2-4019-af2b-aa23c1bb8556 61 fields · synced May 16, 2026
- EUDAMED c7ad8903-d1b6-4fcf-869f-d48e1b897e61 61 fields · synced May 17, 2026
- EUDAMED f0f6a57d-5238-43b3-a706-83039b6153d0 61 fields · synced May 17, 2026
- EUDAMED df44916a-2a36-4dcc-bab3-a3c19c012a8c 61 fields · synced May 17, 2026
- EUDAMED 9f82c4cc-4030-4b20-9db3-b2abf167ee7b 61 fields · synced May 17, 2026
- EUDAMED d734bd2d-fe0b-4ae8-b94f-a2445810ce71 61 fields · synced May 17, 2026
- EUDAMED 7949f2b2-2618-485c-9229-78aaf24fecd5 61 fields · synced May 17, 2026
- EUDAMED fb245d89-ca3d-49a1-87f5-3f94ab904492 61 fields · synced May 17, 2026
- EUDAMED 4c22513e-6921-4918-8ed2-9f976e0d4e7b 61 fields · synced May 18, 2026
- EUDAMED eb48eb11-e562-467a-a96f-8f0fc703155b 61 fields · synced May 18, 2026
- EUDAMED 456d7615-6e9d-4f5a-b951-8394d36c6eb6 61 fields · synced May 18, 2026
- EUDAMED 714cc10e-9e2c-438b-8741-8d4c7ad34a74 61 fields · synced May 18, 2026
- EUDAMED 269d47cd-e0a3-48e7-b309-9c5d2a10ccf6 61 fields · synced May 18, 2026
- EUDAMED 4f8c0ba4-b5ef-46e6-99c9-cc54cd631506 61 fields · synced May 18, 2026
- EUDAMED 5aad90d2-1c73-4c35-b309-d45f70b443c5 61 fields · synced May 18, 2026
- EUDAMED 78b53a05-75cf-4a32-af09-129a39561c94 61 fields · synced May 18, 2026
- EUDAMED b8a0c71d-c4e5-420b-b870-36cb28520c51 61 fields · synced May 18, 2026
- EUDAMED 2fda67eb-fe65-4561-b501-b26b7d6ef90e 61 fields · synced May 18, 2026
- EUDAMED d5e10c69-7b7c-49d5-b47a-359c944c6ead 61 fields · synced May 18, 2026
- EUDAMED c42936b8-8c64-4c75-94b2-29ca1e1c0708 61 fields · synced May 18, 2026
- EUDAMED a9069568-ede1-4b3d-ba06-a553526b1646 61 fields · synced May 18, 2026
- EUDAMED 5f5d34de-b5c3-412b-bbf6-50979214b6f1 61 fields · synced May 18, 2026
- EUDAMED e4da3824-87a6-43c9-b793-fb11b2a8fe40 61 fields · synced May 18, 2026
- EUDAMED 245f91d4-1920-4797-b239-83096dade7c5 61 fields · synced May 19, 2026
- EUDAMED 0ab18d85-dfd3-4995-aaee-0f14beecb886 61 fields · synced May 19, 2026
- EUDAMED 9e762e65-96d3-4d83-a6cc-e7cf37bb0fd9 61 fields · synced May 19, 2026
- EUDAMED 52cbff29-20bd-46c6-98bd-88e9886db01d 61 fields · synced May 19, 2026