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Diagnostic Ultrasound System
EUDAMEDClass IIa (EU MDR)
Ref Rocvue T8 PlusModel Rocvue T series
Identity
- Device Name
- Diagnostic Ultrasound System EUDAMED
- Model / Reference
- Rocvue T series EUDAMEDRocvue T8 Plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975329590669 EUDAMED
- Basic UDI-DI
- 697532959A012000152 EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) 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 (1)
- EUDAMED 1b3e076f-ce20-40a5-8e06-b50367e0e346 61 fields · synced Jun 18, 2026