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Versana Premier, Versana Premier Lotus
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Versana Premier Lotus 5PP/5938561Model Versana Premier, Versana Premier LotusRef Versana Premier Lotus 4PPRef Versana Premier R3 VS
Identity
- Trade Name
- Versana FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Versana Premier, Versana Premier Lotus EUDAMEDMagna R3 VS Basic console FDA UDIMagna R3 LOTUS 4pp Basic console FDA UDIMagna R3 LOTUS 5pp Basic console FDA UDI
- Model / Reference
- Versana Premier, Versana Premier Lotus EUDAMEDVersana Premier Lotus 5PP/5938561 EUDAMEDVersana Premier Lotus 4PP EUDAMEDVersana Premier R3 VS EUDAMEDPremier R3 VS FDA UDIPremier LOTUS 4PP FDA UDIPremier LOTUS 5PP FDA UDI
- Description
- Magna R3 VS Basic console FDA UDIMagna R3 LOTUS 4pp Basic console FDA UDIMagna R3 LOTUS 5pp Basic console FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278690418 EUDAMEDFDA UDI00195278690388 EUDAMEDFDA UDI00195278690401 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00189HT EUDAMED
- 510(k) Number
- K242005 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO 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
- 892.1570 FDA UDI892.1560 FDA UDI892.1550 FDA UDI
- Market of Registration
- France EUDAMEDCzechia EUDAMEDGermany 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
MR Unsafe FDA UDI
Versana Premier, Versana Premier Lotus 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 | 8406821BUG00189HT | 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 (6)
- EUDAMED 60e5a9ee-6f3f-45ec-a569-4afa21bc0cd1 61 fields · synced Oct 6, 2026
- FDA UDI 4fcc3413-5c7d-4d0d-ad11-844313ea5069 35 fields · synced May 30, 2026
- FDA UDI 2d8279fa-c037-488c-9f22-cc6e845f4930 35 fields · synced May 30, 2026
- FDA UDI de9470c8-4088-4e4c-bf2f-56fe4c4b57e7 35 fields · synced May 30, 2026
- EUDAMED 99c3cc2b-a524-43e5-96a0-8e82a8f6237f 61 fields · synced Jul 9, 2026
- EUDAMED b6d2b8e0-daac-42de-b439-e330dbacce43 61 fields · synced Aug 4, 2026