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Versana Essential
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5887857Model Versana Essential
Identity
- Trade Name
- Versana FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Versana Essential EUDAMEDVersana Essential R2 VS FDA UDI
- Model / Reference
- Versana Essential EUDAMED5887857 EUDAMEDEssential R2 VS FDA UDI
- Description
- Versana Essential R2 VS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278503404 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00287HU EUDAMED
- Direct Marketing DI
- 00195278503404 EUDAMED
- 510(k) Number
- K223407 FDA UDI
- FDA Product Code
- IYO FDA UDIITX FDA UDIIYN FDA UDI
- EMDN Code
- Z11040101 INTERNAL 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
- France 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
Yes
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
Versana Essential by GE Medical Systems CO. Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00287HU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems CO. Ltd
- EUDAMED SRN
- CN-MF-000001856
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED e5d769a3-7718-428c-ac53-c7fa5293418b 61 fields · synced Oct 6, 2026
- FDA UDI 7c50f90c-2041-490a-b9de-6fb9b665b7b9 35 fields · synced May 26, 2026