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Vivid
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Vivid T8 T9 v206 to v208 SW only upgrade kit/5951858Model Vivid T8,Vivid T9
Identity
- Trade Name
- Vivid EUDAMEDFDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Device Name
- Vivid T8,Vivid T9 EUDAMEDVivid T8 T9 v206 to v208 SW only upgrade kit with package FDA UDI
- Model / Reference
- Vivid T8,Vivid T9 EUDAMEDVivid T8 T9 v206 to v208 SW only upgrade kit/5951858 EUDAMEDT8 T9 v206 to v208 SW only upgrade kit FDA UDI
- Description
- Vivid T8 T9 v206 to v208 SW only upgrade kit with package FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278833570 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00255HF EUDAMED
- Direct Marketing DI
- 00195278833570 EUDAMED
- 510(k) Number
- K243628 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- EMDN Code
- Z11040102 CARDIOLOGY ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Cardiovascular ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 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
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
MR Unsafe FDA UDI
Vivid 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 | 8406821BUG00255HF | 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 98534177-ca2d-4c6b-9249-aef7c74a51ea 61 fields · synced May 30, 2026
- FDA UDI 1eef763f-3767-4e71-8a08-2408e191a62d 35 fields · synced May 30, 2026