Identity
- Trade Name
- 2Tx32Rx 7T Head Coil EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 2Tx32Rx 7T Head Coil EUDAMED2Tx32Rx 7T Head Coil for GE FDA UDI
- Model / Reference
- 4318932 EUDAMEDFDA UDI
- Description
- 2Tx32Rx 7T Head Coil for GE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866613000338 EUDAMEDFDA UDI
- Basic UDI-DI
- 086661300037T4318932Z2 EUDAMED
- Direct Marketing DI
- 00866613000338 EUDAMED
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z11059080 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Italy 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
2Tx32Rx 7T Head Coil by Nova Medical Inc — 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 | 086661300037T4318932Z2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Nova Medical Inc
- EUDAMED SRN
- US-MF-000009719
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 342cf537-9e2f-45b0-a32a-90612ca9ae31 61 fields · synced Sep 18, 2026
- FDA UDI fac2898c-f9ed-4047-b26c-7b084431e8e8 34 fields · synced May 29, 2026