← Back to catalogue
SonoSite Edge II
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P20680-18RModel SONOSITE EDGE II ULTRASOUND SYSTEMRef P30380-16Ref P20680-12Ref P20680-14RModel EDGE II ULTRASOUND SYSTEMRef P30380-02Ref P20680-17RRef P30380-15Model SONOSITE EDGE II ULTRASOUND SYSTEM, 4.1
Identity
- Trade Name
- SonoSite Edge II EUDAMEDFDA UDISonoSite Edge EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- SONOSITE EDGE II ULTRASOUND SYSTEM EUDAMEDEDGE II ULTRASOUND SYSTEM EUDAMEDSONOSITE EDGE II ULTRASOUND SYSTEM, 4.1 EUDAMEDDiagnostic ultrasound system FDA UDIDiagnostic ultrasound device FDA UDISONOSITE EDGE II ULTRASOUND SYSTEM, INDIA FDA UDI
- Model / Reference
- SONOSITE EDGE II ULTRASOUND SYSTEM EUDAMEDP20680-18R EUDAMEDFDA UDIP20680-14R EUDAMEDFDA UDIP20680-12 EUDAMEDFDA UDIP30380-15 EUDAMEDFDA UDIP30380-02 EUDAMEDFDA UDIP20680-17R EUDAMEDFDA UDIP30380-16 EUDAMEDEDGE II ULTRASOUND SYSTEM EUDAMEDSONOSITE EDGE II ULTRASOUND SYSTEM, 4.1 EUDAMED
- Description
- Diagnostic ultrasound system FDA UDIDiagnostic ultrasound device FDA UDISONOSITE EDGE II ULTRASOUND SYSTEM, INDIA FDA UDI
Identifiers
- Catalog Number
- P20680 FDA UDIP30380 FDA UDI
- Primary DI / UDI-DI
- 00841517105518 EUDAMEDFDA UDI00841517103644 EUDAMEDFDA UDI00841517101978 EUDAMEDFDA UDI00841517109776 EUDAMEDFDA UDI00841517107925 EUDAMEDFDA UDI00841517104504 EUDAMEDFDA UDI00841517111397 EUDAMED
- Basic UDI-DI
- 08415171EDGEII8S EUDAMEDB-00841517101978 EUDAMEDB-00841517103644 EUDAMEDB-00841517107925 EUDAMEDB-00841517104504 EUDAMEDB-00841517109776 EUDAMED
- FDA Product Code
- IYO FDA UDIITX FDA UDIIYN FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI892.1550 FDA UDI
- Market of Registration
- Italy 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 Edge II by Fujifilm Sonosite, Inc. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 08415171EDGEII8S | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08415171EDGEII8S | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (13)
- EUDAMED 84627b8f-a64b-4f48-adab-8c604ca4ae1c 61 fields · synced Aug 3, 2026
- FDA UDI d6bc10dc-bf43-443d-9cf5-c3e52226fba2 37 fields · synced May 29, 2026
- FDA UDI fa7d62e7-4528-4ac0-9223-a5fc5426dc22 37 fields · synced May 29, 2026
- FDA UDI cd51fabd-0c14-4b5f-b0d9-f7329fe531a7 36 fields · synced May 30, 2026
- FDA UDI 365dc54d-1a28-4a14-b470-95c835385fd8 36 fields · synced May 30, 2026
- FDA UDI 310ddecf-3d71-450f-bb29-6d7982f66c79 36 fields · synced May 30, 2026
- FDA UDI 7a84a0b8-83ef-45f3-befd-e9c4dc0979b6 36 fields · synced May 30, 2026
- EUDAMED 2b785acf-2ae3-4258-abf4-5ba49c310958 61 fields · synced Jul 11, 2026
- EUDAMED b9b51bf2-586c-4bb5-aff5-696b9b283a7f 61 fields · synced Jul 12, 2026
- EUDAMED ec7c4ef1-1802-4201-8d3e-59a1ddf70b9c 61 fields · synced Jul 14, 2026
- EUDAMED 75f3ef26-3b69-48d3-bd0c-9d0eb1603e58 61 fields · synced Jul 15, 2026
- EUDAMED 4533db79-dbc3-4684-b51f-7c80164745bb 61 fields · synced Jul 18, 2026
- EUDAMED 8344a5cc-9ed3-47a2-8e51-82cc59163b1b 61 fields · synced Aug 3, 2026