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GEM Flex Interface 16ch Fixed, 3.0T P-Connector
EUDAMEDFDA UDIClass I (EU MDR)
Ref NC032204Model GEM Flex Coil
by NeoCoil, LLC
Identity
- Trade Name
- GEM Flex Interface 16ch Fixed, 3.0T P-Connector EUDAMED3.0T GEM Flex Interface, P-Connector FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- GEM Flex Coil EUDAMED
- Model / Reference
- GEM Flex Coil EUDAMEDNC032204 EUDAMED14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003145 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932407D EUDAMED
- Direct Marketing DI
- 00856181003145 EUDAMED
- 510(k) Number
- K103342 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
- Netherlands 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
GEM Flex Interface 16ch Fixed, 3.0T P-Connector by Neocoil, Llc — 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 | 0850028932407D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NeoCoil, LLC
- EUDAMED SRN
- US-MF-000027128
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0afb86be-01c4-48bc-a5cf-6a1d27e0a8ec 61 fields · synced Jul 10, 2026
- FDA UDI 24d9e922-394b-45d5-a26b-25ad6c15224a 33 fields · synced May 30, 2026