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1.5T Express Coil – 16E Head Neck Array
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5407991
Identity
- Trade Name
- 1.5T Express Coil – 16E Head Neck Array EUDAMEDNA FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 1.5T Express Coils 9E AA and 16E HNS Array EUDAMED1.5T 16 CHANNEL,HEAD NECK ARRAY FDA UDI
- Model / Reference
- 5407991 EUDAMED1.5T EXPRESS COIL - 16E HEAD NECK ARRAY FDA UDI
- Description
- 1.5T 16 CHANNEL,HEAD NECK ARRAY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682118958 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00369HX EUDAMED
- 510(k) Number
- K123417 FDA UDI
- FDA Product Code
- LNH 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
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
Category: MRI system coil, radio-frequency
1.5T Express Coil – 16E Head Neck Array by GE Healthcare Tianjin Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 8406821BUG00369HX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Tianjin Company Limited
- EUDAMED SRN
- CN-MF-000001725
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 0ee8cc60-d356-4c2f-9d23-0e6ce203fa3c 61 fields · synced Oct 6, 2026
- FDA UDI 24a2ab12-5021-4500-b0b4-29a85d32aca0 34 fields · synced May 30, 2026