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Sonosite MT Power Supply
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref P33004-04Model AC/DC POWER SUPPLYRef P33000-10Model SONOSITE MT ULTRASOUND SYSTEM
Identity
- Trade Name
- Sonosite MT Power Supply EUDAMEDSonosite MT EUDAMED
- Device Name
- AC/DC POWER SUPPLY EUDAMEDSONOSITE MT ULTRASOUND SYSTEM EUDAMED
- Model / Reference
- AC/DC POWER SUPPLY EUDAMEDP33004-04 EUDAMEDSONOSITE MT ULTRASOUND SYSTEM EUDAMEDP33000-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517111892 EUDAMED00841517112165 EUDAMED
- Basic UDI-DI
- 08415171PowersupplyMT2K EUDAMED08415171MT86 EUDAMED
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMEDZ11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- France EUDAMEDSpain 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 MT Power Supply by Fujifilm Sonosite, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253448 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 08415171PowersupplyMT2K | 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 (3)
- EUDAMED fadf5c5f-9c33-44bc-9bf0-d8b234069b9f 61 fields · synced Jul 26, 2026
- EUDAMED 0380eb80-70e7-464e-9313-e84d5f02102e 61 fields · synced May 18, 2026
- FDA 510(k) K253448 1 fields · synced May 18, 2026