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1.5T 30ch AIR AA
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1.5T 30ch AIR AAModel 3.0T AIR Anterior/Posterior Arrays, 1.5T 30CH AIR AA, 1.5T AIR Posterior Array, and 3.0T AIR PA XL
Identity
- Trade Name
- 1.5T 30ch AIR AA EUDAMEDNA FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 3.0T AIR Anterior/Posterior Arrays, 1.5T 30CH AIR AA, 1.5T AIR Posterior Array, and 3.0T AIR PA XL EUDAMED
- Model / Reference
- 3.0T AIR Anterior/Posterior Arrays, 1.5T 30CH AIR AA, 1.5T AIR Posterior Array, and 3.0T AIR PA XL EUDAMED1.5T 30ch AIR AA EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682142939 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00310GW EUDAMED
- 510(k) Number
- K182590 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
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
Category: MRI system coil, radio-frequency
1.5T 30ch AIR AA by GE Healthcare Coils — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 8406821BUG00310GW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Coils
- EUDAMED SRN
- US-MF-000001664
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 5059d6e0-a907-4f95-b01d-c8d384592dcb 61 fields · synced Jun 19, 2026
- FDA UDI d00ab5ac-fcac-4f8d-bc50-35044f01a30f 33 fields · synced May 30, 2026