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Ultrasonic Diagnostic System
EUDAMEDClass IIa (EU MDR)
Ref Ultrasonic Diagnostic SystemModel Piloter RModel Piloter Exp, Piloter, Piloter T, Piloter PE, Piloter P, Piloter S, Piloter B, Piloter D, Piloter F, Piloter R, Piloter RE, Piloter V, Piloter U, Piloter SE, Piloter i, Piloter X
Identity
- Trade Name
- Ultrasonic Diagnostic System EUDAMED
- Device Name
- Ultrasonic Diagnostic System EUDAMED
- Model / Reference
- Piloter R EUDAMEDUltrasonic Diagnostic System EUDAMEDPiloter Exp, Piloter, Piloter T, Piloter PE, Piloter P, Piloter S, Piloter B, Piloter D, Piloter F, Piloter R, Piloter RE, Piloter V, Piloter U, Piloter SE, Piloter i, Piloter X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355420512 EUDAMED
- Basic UDI-DI
- B-06971355420512 EUDAMED697135542U05PA 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 — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06971355420512 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971355420512 | 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 6ffbfc99-1ba7-4c4b-a460-e5fe0c671337 61 fields · synced Oct 6, 2026
- EUDAMED 57b763b4-b74c-4c15-bc5c-eed1cc7bf1f2 61 fields · synced May 19, 2026