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Sonosite PX
EUDAMEDClass I (EU MDR)
Ref P33206-01Model SONOSITE MICROPHONE ACCESSORY
Identity
- Trade Name
- Sonosite PX EUDAMED
- Device Name
- SONOSITE MICROPHONE ACCESSORY EUDAMED
- Model / Reference
- SONOSITE MICROPHONE ACCESSORY EUDAMEDP33206-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517110239 EUDAMED
- Basic UDI-DI
- B-00841517110239 EUDAMED
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
Classification
- Device Class
- Class I 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 I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841517110239 | 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 fc28b1c3-247b-4e18-8380-49bd88210349 61 fields · synced May 23, 2026