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SonoSite M-Turbo
EUDAMEDFDA UDIClass I (EU MDR)
Ref P30397-16Model M-TURBO ULTRASOUND SYSTEMRef P08189-95Ref P08189-77RRef P08189-95R
Identity
- Trade Name
- SonoSite M-Turbo EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- M-TURBO ULTRASOUND SYSTEM EUDAMED
- Model / Reference
- M-TURBO ULTRASOUND SYSTEM EUDAMEDP30397-16 EUDAMEDP08189-95 EUDAMEDP08189-77R EUDAMEDFDA UDIP08189-95R EUDAMED
Identifiers
- Catalog Number
- P08189 FDA UDI
- Primary DI / UDI-DI
- 00841517111410 EUDAMED00841517106720 EUDAMED00841517102982 EUDAMEDFDA UDI00841517106713 EUDAMED
- Basic UDI-DI
- B-00841517111410 EUDAMEDB-00841517106720 EUDAMED08415171MTURBONC EUDAMEDB-00841517106713 EUDAMED
- 510(k) Number
- K130173 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX FDA UDI
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMEDZ11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 FDA UDI892.1570 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SonoSite M-Turbo by Fujifilm Sonosite, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00841517111410 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00841517111410 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (5)
- EUDAMED 85634922-985b-4403-b893-ca5d77833caa 61 fields · synced Jul 20, 2026
- EUDAMED d7b48bb9-a851-4546-92ff-f3c36e0f1445 61 fields · synced May 18, 2026
- EUDAMED 2c630240-0f0a-4ca4-9599-f9e50d9417f0 61 fields · synced May 18, 2026
- EUDAMED c128a22a-86be-49f0-9a54-0efa07dc17b3 61 fields · synced May 19, 2026
- FDA UDI 0bb426d9-4707-4333-a6d9-2ce76ffa75cb 36 fields · synced May 30, 2026