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Sonosite PX
EUDAMEDClass IIa (EU MDR)
Ref P31060-05Model SONOSITE PX ULTRASOUND SYSTEM
Identity
- Trade Name
- Sonosite PX EUDAMED
- Device Name
- SONOSITE PX ULTRASOUND SYSTEM EUDAMED
- Model / Reference
- SONOSITE PX ULTRASOUND SYSTEM EUDAMEDP31060-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517111908 EUDAMED
- Basic UDI-DI
- 08415171PX8P EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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 PX by Fujifilm Sonosite, Inc. — 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 | 08415171PX8P | Class IIa | 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 755157fd-8c3a-4d99-8dcb-8401b8aa0095 61 fields · synced May 23, 2026