Identity
- Trade Name
- Fenix 80T EUDAMED
- Device Name
- Digital Color Doppler Ultrasound System EUDAMED
- Model / Reference
- S90 Exp EUDAMED_ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945868615505 EUDAMED
- Basic UDI-DI
- 69458686U1017SQ 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fenix 80T by Sonoscape Medical Corp. — 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 | 69458686U1017SQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sonoscape Medical Corp.
- EUDAMED SRN
- CN-MF-000009623
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED bde6db6c-a489-45f0-968d-8e40f8d7ba88 61 fields · synced Jul 10, 2026