GEM Flex Coil 16-S Array, 3.0T Receive Only
EUDAMEDFDA UDIClass I (EU MDR)
by NeoCoil, LLC
Identity
- Trade Name
- GEM Flex Coil 16-S Array, 3.0T Receive Only EUDAMED3.0T GEM Flex Coil 16-S Array FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- GEM Flex Coil EUDAMED
- Model / Reference
- GEM Flex Coil EUDAMEDNC034200 EUDAMED11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003114 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932407D EUDAMED
- Direct Marketing DI
- 00856181003114 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
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 Coil 16-S Array, 3.0T Receive Only by Neocoil, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI system coil, radio-frequency.
- Dunlee Sentinelle — Philips Medical Systems Nederland B.V. · Class II
- All-Purpose Arch — NORAS MRI products GmbH · Class II
- LEYLA Retractor Socket — NORAS MRI products GmbH · Class II
- All-Purpose Arch Adapter — NORAS MRI products GmbH · Class II
- Operator's Manual Flexibility Siemens — NORAS MRI products GmbH · Class II
- NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH · Class II
- ScanMed Long Bone (L) Coil — SCANMED, LLC · Class II
- Variety Positioning Aid Set Pediatrics — NORAS MRI products GmbH · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NeoCoil, LLC
- EUDAMED SRN
- US-MF-000027128
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 31ca5e9d-d006-4edf-99bc-74f330c5ba3f 61 fields · synced Jun 18, 2026
- FDA UDI ca52c8f8-178d-4497-82e5-af76dc22adc1 33 fields · synced May 30, 2026