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Versana Essential
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5887882Model Versana Essential
Identity
- Trade Name
- Versana FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Versana Essential EUDAMEDVersana Essiential R2 VA FDA UDI
- Model / Reference
- Versana Essential EUDAMED5887882 EUDAMEDEssential R2 VA FDA UDI
- Description
- Versana Essiential R2 VA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278503411 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00287HU EUDAMED
- Direct Marketing DI
- 00195278503411 EUDAMED
- 510(k) Number
- K223407 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITZ 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
- 892.1550 FDA UDI892.1560 FDA UDI892.5930 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 8f484a1d-d61f-446a-9433-996a633b42a0 61 fields · synced Oct 6, 2026
- FDA UDI 4a6982c7-0bd5-4358-b2d1-2570f4c56f1e 35 fields · synced May 26, 2026