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Sonosite ZX Stand Head
EUDAMEDClass I (EU MDR)
Ref P32503-02Model STAND HEAD, SONOSITE ZX
Identity
- Trade Name
- Sonosite ZX Stand Head EUDAMED
- Device Name
- STAND HEAD, SONOSITE ZX EUDAMED
- Model / Reference
- STAND HEAD, SONOSITE ZX EUDAMEDP32503-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517111373 EUDAMED
- Basic UDI-DI
- 08415171StandheadDD 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 Head 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 | 08415171StandheadDD | Class I | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (1)
- EUDAMED c41f801a-7c8e-4144-a1ec-b89ba07c68ee 61 fields · synced Jul 9, 2026