← Back to catalogue
Sonosite ZX Stand
EUDAMEDClass I (EU MDR)
Ref P32504-02Model PORTABLE SYSTEM, SONOSITE ZX
Identity
- Trade Name
- Sonosite ZX Stand EUDAMED
- Device Name
- PORTABLE SYSTEM, SONOSITE ZX EUDAMED
- Model / Reference
- PORTABLE SYSTEM, SONOSITE ZX EUDAMEDP32504-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517111380 EUDAMED
- Basic UDI-DI
- 08415171ZXStandJ3 EUDAMED
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Sonosite ZX Stand by Fujifilm Sonosite, Inc. — Class I — 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 | 08415171ZXStandJ3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (1)
- EUDAMED bb245f06-e858-43b2-ae8c-eb45833c076d 61 fields · synced Jun 17, 2026