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Pediatric Stabilizer, Flex Coils
EUDAMEDFDA UDIClass I (EU MDR)
Ref NC074003Model Flex Coil Accessories
by NeoCoil, LLC
Identity
- Trade Name
- Pediatric Stabilizer, Flex Coils EUDAMEDFlex Coils Pediatric Stabilizer System FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Flex Coil Accessories EUDAMEDThese accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil. FDA UDI
- Model / Reference
- Flex Coil Accessories EUDAMEDNC074003 EUDAMED62 FDA UDI
- Description
- These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003626 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932357L EUDAMED
- 510(k) Number
- K113474 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018099 MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pediatric Stabilizer, Flex Coils 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 | 0850028932357L | 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 faa44694-155f-4c14-9366-da943dbce8f2 61 fields · synced Jul 10, 2026
- FDA UDI d0801a2a-9c8d-46a2-a93d-a76b6d266eb4 34 fields · synced May 30, 2026