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Vivid T8, Vivid T9
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Vivid T8 v206/5876955Model Vivid T8,Vivid T9
Identity
- Trade Name
- Vivid FDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Device Name
- Vivid T8,Vivid T9 EUDAMEDT8 v206 console FDA UDI
- Model / Reference
- Vivid T8,Vivid T9 EUDAMEDVivid T8 v206/5876955 EUDAMEDT8 v206 FDA UDI
- Description
- T8 v206 console FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278422286 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00255HF EUDAMED
- Direct Marketing DI
- 00195278422286 EUDAMED
- 510(k) Number
- K221147 FDA UDI
- FDA Product Code
- IYN FDA UDIITX 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
- 892.1550 FDA UDI892.1570 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
No
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 T8, Vivid T9 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 fcedb404-b490-4e4a-a799-fcaa89f68d83 61 fields · synced Oct 6, 2026
- FDA UDI 248d4b67-35ce-438b-86f3-d399d065dcc9 35 fields · synced May 30, 2026