3.0T GE 6-Channel Phased Array Flex Coil
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- 3.0T GE 6-Channel Phased Array Flex Coil EUDAMEDNA FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 1.5T and 3T 6 Channel Phased Array Flex Coil EUDAMED
- Model / Reference
- 1.5T and 3T 6 Channel Phased Array Flex Coil EUDAMED5363393 EUDAMED3.0T GE 6-Channel Phased Array Flex Coil FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682119597 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00357HQ EUDAMED
- 510(k) Number
- K110610 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: MRI system coil, radio-frequency
3.0T GE 6-Channel Phased Array Flex Coil by GE Medical Systems, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00357HQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems LLC
- EUDAMED SRN
- US-MF-000001632
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED a51b8b0c-981b-4b8b-85e3-23a93838e4ce 61 fields · synced Jul 13, 2026
- FDA UDI c354e82d-dcb3-4b38-b35e-daa7419517fe 33 fields · synced May 24, 2026