Identity
- Trade Name
- 3T 32 CH Head Coil MR 750 EUDAMED3T 32 CH Head Coil FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 3T 32 CH Head Coil for GE EUDAMED3T 32 CH Head Coil device for GE MR750 FDA UDI
- Model / Reference
- 3832016 EUDAMEDFDA UDI
- Description
- 3T 32 CH Head Coil device for GE MR750 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866613000307 EUDAMEDFDA UDI
- Basic UDI-DI
- 086661300033T32CHJ9 EUDAMED
- Direct Marketing DI
- 00866613000307 EUDAMED
- 510(k) Number
- K182737 FDA UDI
- 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 I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Belgium 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
3T 32 CH Head Coil MR 750 by Nova Medical Inc — Class I — 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 | 086661300033T32CHJ9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 9bd449ba-5274-4062-8300-1ce440f28c85 61 fields · synced Jul 21, 2026
- FDA UDI db7c2a3e-8b23-476b-9a08-538150e01435 35 fields · synced May 30, 2026