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GEM Flex Coil 16-L Array, 3.0T Receive Only
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref NC040200Model GEM Flex Coil510(k) K252876
by NeoCoil, LLC
Identity
- Trade Name
- GEM Flex Coil 16-L Array, 3.0T Receive Only EUDAMED3.0T GEM Flex Coil 16-L Array FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- GEM Flex Coil EUDAMED
- Model / Reference
- GEM Flex Coil EUDAMEDNC040200 EUDAMED13 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003138 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932407D EUDAMED
- Direct Marketing DI
- 00856181003138 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 Coil 16-L Array, 3.0T Receive Only by Neocoil, Llc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252876 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850028932407D | Class I | Active |
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Manufacturer
- Manufacturer
- NeoCoil, LLC
- EUDAMED SRN
- US-MF-000027128
- FDA Applicant
- Shenzhen RF Tech Co., Ltd.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 7589a7c7-fe01-4a35-aadd-9a3c763fa712 85 fields · synced Jun 18, 2026
- FDA UDI d4834de6-9d62-4ba9-9a10-5b1e3d028a2d 33 fields · synced May 27, 2026
- FDA 510(k) K252876 1 fields · synced May 18, 2026