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Ultrasonic Diagnostic System
EUDAMEDClass IIa (EU MDR)
Ref Lotus 6UltraModel Lotus, Lotus T, Lotus Go, Lotus Pro, Lotus Elite, Lotus Ultra, Lotus 5T, Lotus 5Go, Lotus 5Pro, Lotus 5Elite, Lotus 5Ultra, Lotus 6Go, Lotus 6T, Lotus 6Pro, Lotus 6Elite, Lotus 6UltraRef Lotus EliteRef LotusRef Lotus 5ProRef Lotus 6EliteRef Lotus TRef Lotus UltraRef Lotus ProRef Lotus GoRef Lotus 5Go
Identity
- Trade Name
- Ultrasonic Diagnostic System EUDAMED
- Device Name
- Ultrasonic Diagnostic System EUDAMED
- Model / Reference
- Lotus, Lotus T, Lotus Go, Lotus Pro, Lotus Elite, Lotus Ultra, Lotus 5T, Lotus 5Go, Lotus 5Pro, Lotus 5Elite, Lotus 5Ultra, Lotus 6Go, Lotus 6T, Lotus 6Pro, Lotus 6Elite, Lotus 6Ultra EUDAMEDLotus 6Ultra EUDAMEDLotus Elite EUDAMEDLotus EUDAMEDLotus 5Pro EUDAMEDLotus 6Elite EUDAMEDLotus T EUDAMEDLotus Ultra EUDAMEDLotus Pro EUDAMEDLotus Go EUDAMEDLotus 5Go EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355421168 EUDAMED06971355421052 EUDAMED06971355421014 EUDAMED06971355421090 EUDAMED06971355421151 EUDAMED06971355421021 EUDAMED06971355421069 EUDAMED06971355421045 EUDAMED06971355421038 EUDAMED06971355421083 EUDAMED
- Basic UDI-DI
- 697135542U07PE 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 — 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 | 697135542U07PE | 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 (10)
- EUDAMED 3b2e31a7-f06e-45b8-b9ae-339b04a25299 61 fields · synced Oct 6, 2026
- EUDAMED 45bd76ed-1c9b-477c-a266-9687e4e24bfc 61 fields · synced May 17, 2026
- EUDAMED 76f9a49e-c7a1-4cf9-af1d-2dad87c09820 61 fields · synced May 17, 2026
- EUDAMED e299f0b0-9bfb-4c6d-93ec-b37012f447a4 61 fields · synced May 17, 2026
- EUDAMED ca847f31-9a07-44e9-b774-51eb4625bc1d 61 fields · synced May 18, 2026
- EUDAMED c4bbdc08-c4ba-4bb8-9038-704f64858e27 61 fields · synced May 18, 2026
- EUDAMED 77ca98c4-27c7-4c26-8b74-0a86299dc135 61 fields · synced May 18, 2026
- EUDAMED 6b95f119-4b58-4862-98bf-47e492536636 61 fields · synced May 18, 2026
- EUDAMED c0742265-485e-45b3-a90d-c64bdb43e7a7 61 fields · synced May 18, 2026
- EUDAMED 8243ecde-590d-4480-8dcb-c67a442bf11b 61 fields · synced May 19, 2026