← Back to catalogue

Ultrasonic Diagnostic System

EUDAMED

Class IIa (EU MDR)

Ref Lotus 5UltraModel 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

by Shenzhen Wisonic Medical Technology Co., Ltd.

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 EUDAMED
Lotus 5Ultra EUDAMED

Identifiers

Primary DI / UDI-DI
06971355421113 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

Is this your device? Claim it to add documentation and request validation.

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 (1)

  • EUDAMED 0faa7edc-0317-4c53-95ca-9ec479e7d568 61 fields · synced Jun 18, 2026