GEM Flex Pediatric Interface, 16ch, 1.5T P-Connector
EUDAMEDFDA UDIClass I (EU MDR)
by NeoCoil, LLC
Identity
- Trade Name
- GEM Flex Pediatric Interface, 16ch, 1.5T P-Connector EUDAMED1.5T GEM Flex Pediatric Interface, P-Connector FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- GEM Flex Coil EUDAMEDThe NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. FDA UDI
- Model / Reference
- GEM Flex Coil EUDAMEDNC022210 EUDAMED23 FDA UDI
- Description
- The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003237 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932407D EUDAMED
- Direct Marketing DI
- 00856181003237 EUDAMED
- 510(k) Number
- K113474 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: MRI system coil, radio-frequency
GEM Flex Pediatric Interface, 16ch, 1.5T P-Connector by Neocoil, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 4404fc71-f2fe-4e94-bd27-b250d24ce7da 61 fields · synced Jun 18, 2026
- FDA UDI dac3cf1d-b98d-4c72-917a-bb5ee013a296 34 fields · synced May 30, 2026