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NEOCOIL, LLC

United States·US-MF-000027128

Last updated September 17, 2026

Information

Country: United States
Address: N27 W23910A , Paul Rd, Pewaukee, United States
Website: neocoil.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 (262) 522-6124
PRRC Contact: Kate Gonzalez
EUDAMED SRN: US-MF-000027128
FDA FEI Number: 3006369484
DUNS Number: 781155176

Catalogue (108)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
GEM Flex Knee Stabilizer for Flat Tables	56	FDA UDI	Class II	Active
16Ch Flex SPEEDER Pad Kit	72	FDA UDI	Class II	Active
1.5T 16‐Channel Flex Coils for Siemens, Large	44	FDA UDI	Class II	Active
Stand-Alone Wireless Patient Alert	20	FDA UDI	Class II	Active
Extremities Stabilizer Kit, Flex Coils	NC074004	EUDAMED	Class I	Active
1.5T AIR Open Head Anterior 16ch	NC139205	EUDAMEDFDA UDI	Class I	Active
1.5T AIR Open Neck Chest Anterior 7ch	NC139204	EUDAMEDFDA UDI	Class I	Active
ECG CT Gating Device	K160350	FDA 510(k)	Class II	Active
Headphones, Patient Alert, Standalone Interface	K133670	FDA 510(k)	Class II	Active
Neocoil 1.5t 16 Channel Cardiac-Abdominal-Pelvic Array Coil	K073181	FDA 510(k)	Class II	Active
1.5t 16ch Flex Speeder Large, 1.5t 16ch Flex Speeder Medium	K123272	FDA 510(k)	Class II	Active
3.0t Metaflexcoil	K103342	FDA 510(k)	Class II	Active
1.5t 16-Channel Flex Coil, Small 1.5t 16-Channel Flex Coil, Large	K133422	FDA 510(k)	Class II	Active
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil	K201101	FDA 510(k)	Class II	Active
Neocoil 1.5t 8-Channel Shoulder Array Coil	K071311	FDA 510(k)	Class II	Active
Neocoil 3.0t 8-Channel Shoulder Array Coil	K071611	FDA 510(k)	Class II	Active
Neocoil 3.0t 32-Channel Torso Array Coil For Ge	K073236	FDA 510(k)	Class II	Active
Metaflexcoil	K101632	FDA 510(k)	Class II	Active
3.0T 16ch Breast Coil	K173377	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Neocoil 3.0t 6-Channel Carotid Array Coil	K070778	FDA 510(k)	Class II	Active
0.55T 12Ch Breast Coil	K260947	FDA 510(k)	Class II	Active
1.5t 16ch Flex Speeder Large	K121362	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
1.5T 16ch Shoulder Coil	NC143203	EUDAMEDFDA UDI	Class I	Active
1.5T Receive-Only 16ch Flex SPEEDER Medium	NC042200	EUDAMEDFDA UDI	Class I	Active
GEM Flex Coil 16-S Array, 1.5T Receive Only	NC024200	EUDAMEDFDA UDI	Class I	Active
GEM Flex Interface 16ch Fixed, 3.0T P-Connector	NC032204	EUDAMEDFDA UDI	Class I	Active
3T Receive-Only 16ch Flex SPEEDER Large	NC046200	EUDAMEDFDA UDI	Class I	Active
32Ch AIR Open Coil Suite, 3.0T	NC139020	EUDAMEDFDA UDI	Class I	Active
Guardian S1 Wireless Audio System	NC107000	EUDAMED	Class I	Active
3.0T 16ch Shoulder Coil	NC143202	EUDAMEDFDA UDI	Class I	Active
3.0T AIR Open Head Neck Posterior 9ch	NC139200	EUDAMEDFDA UDI	Class I	Active
GEM Flex Coil 16-L Array, 1.5T Receive Only	NC030200	EUDAMEDFDA UDI	Class I	Active
Guardian G1 Wireless Audio System, HP	NC070004	EUDAMED	Class I	Active
Guardian S2 Wireless Audio System	NC130000	EUDAMED	Class I	Active
3.0T HD 8Ch Shoulder Coil	NC009901	EUDAMEDFDA UDI	Class I	Active
GEM Flex Interface 16ch Fixed, 1.5T P-Connector	NC022204	EUDAMEDFDA UDI	Class I	Active
32Ch AIR Open Coil Suite, 1.5T	NC139021	EUDAMEDFDA UDI	Class I	Active
Elbow and Wrist Stabilizer, Flex Coils	NC074002	EUDAMEDFDA UDI	Class I	Active
1.5T AIR Open Head Neck Posterior 9ch	NC139203	EUDAMEDFDA UDI	Class I	Active
Pediatric SPEEDER Stabilizer	NC036200	EUDAMEDFDA UDI	Class I	Active
GEM Flex Coil 16-S Array, 3.0T Receive Only	NC034200	EUDAMEDFDA UDI	Class I	Active
GEM Flex Coil 16-M Array, 3.0T Receive Only	NC033200	EUDAMEDFDA UDI	Class I	Active
1.5T HD 8Ch Shoulder Coil	NC008901	EUDAMEDFDA UDI	Class I	Active
1.5T 16ch Breast Coil	M7006PH	EUDAMEDFDA UDI	Class I	Active
Biopsy Grid	NC088444	EUDAMED	Class I	Active
Pediatric Stabilizer, Flex Coils	NC074003	EUDAMEDFDA UDI	Class I	Active
Guardian G1 Wireless Audio System	NC070000	EUDAMED	Class I	Active
3.0T AIR Open Neck Chest Anterior 7ch	NC139201	EUDAMEDFDA UDI	Class I	Active
GEM Flex Coil 16-M Array, 1.5T Receive Only	NC023200	EUDAMEDFDA UDI	Class I	Active
Knee Stabilizer, Flex Coils	NC074001	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 17, 2016	Z-2312-2016	—	terminated	There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
Dec 18, 2015	Z-1027-2016	—	terminated	Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.