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Vivid
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Vivid T8 v208/5646560Model Vivid T8,Vivid T9
Identity
- Trade Name
- Vivid EUDAMEDFDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Device Name
- Vivid T8,Vivid T9 EUDAMEDT8 v208 console FDA UDI
- Model / Reference
- Vivid T8,Vivid T9 EUDAMEDVivid T8 v208/5646560 EUDAMEDT8 v208 FDA UDI
- Description
- T8 v208 console FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278796462 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00255HF EUDAMED
- Direct Marketing DI
- 00195278796462 EUDAMED
- 510(k) Number
- K243628 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN 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 UDI892.1560 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
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 312f0883-e117-453f-a91b-cc551cffe3d2 61 fields · synced May 30, 2026
- FDA UDI 34062423-eb41-49d4-9e59-d80e4690244d 34 fields · synced May 30, 2026