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Ultrasonic Diagnostic System
EUDAMEDClass IIa (EU MDR)
Ref Navi uModel Navi i, Navi s, Navi e, Navi u, Navi T, Navi X
Identity
- Trade Name
- Ultrasonic Diagnostic System EUDAMED
- Device Name
- Ultrasonic Diagnostic System EUDAMED
- Model / Reference
- Navi i, Navi s, Navi e, Navi u, Navi T, Navi X EUDAMEDNavi u EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355420420 EUDAMED
- Basic UDI-DI
- 697135542U04P8 EUDAMEDB-06971355420420 EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ultrasonic Diagnostic System by Shenzhen Wisonic Medical Technology Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697135542U04P8 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697135542U04P8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Wisonic Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005656
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 48320c47-43f7-49fb-8274-ebac490d7455 61 fields · synced Jun 19, 2026
- EUDAMED ab4af2a0-7d25-4424-8e49-7931c7b4a086 61 fields · synced May 16, 2026