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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 1 of 3

Device	Model / Reference	Registries	Class	Status
Pen Panel Transmitter Box	21	FDA UDI	Class II	Active
Router Assembly	79	FDA UDI	Class II	Active
3T 16ch Breast Coil	45	FDA UDI	Class II	Active
General Purpose Support strap	65	FDA UDI	Class II	Active
1.5T 16ch Shoulder Coil (FRU)	95	FDA UDI	Class II	Active
16ch Shoulder Coil, Replacement Pad Kit (FRU)	96	FDA UDI	Class II	Active
11 x 6.5 x 1.5 pad	53	FDA UDI	Class II	Active
Stand-Alone Wireless Audio Headphones	19	FDA UDI	Class II	Active
wrist pad	52	FDA UDI	Class II	Active
PCE Pen Panel Transmitter Box	41	FDA UDI	Class II	Active
5 x 3 x 1 pad	48	FDA UDI	Class II	Active
ECG CT Gating Receiver	32	FDA UDI	Class II	Active
Cable Take-up pad	45	FDA UDI	Class II	Active
3T 32Ch Torso Coil - Posterior	03	FDA UDI	Class II	Active
Shoulder Coil Strap assembly	55	FDA UDI	Class II	Active
Preamp Box Foam Sleeve	63	FDA UDI	Class II	Active
1.5T GEM Flex Interface, 8ch Combined, HD-Connector	58	FDA UDI	Class II	Active
U-shaped large pad	51	FDA UDI	Class II	Active
3.0T 16ch Shoulder Coil (FRU)	94	FDA UDI	Class II	Active
Pediatric SPEEDER Stabilizer Kit	74	FDA UDI	Class II	Active
3T 32Ch Torso Coil - Anterior	02	FDA UDI	Class II	Active
11 x 6.5 x 1.5 wedge pad	54	FDA UDI	Class II	Active
Wireless Audio Interface	39	FDA UDI	Class II	Active
7.5 x 3.5 x 2 pad	47	FDA UDI	Class II	Active
11 x 6.5 x 3 pad	46	FDA UDI	Class II	Active
Sentinel P2 Audio Interface Module	77	FDA UDI	Class II	Active
ECG CT Gating Cable	33	FDA UDI	Class II	Active
Family Pack, foam kit	71	FDA UDI	Class II	Active
3.0T 16ch Shoulder Coil (System)	92	FDA UDI	Class II	Active
1.5T 16ch Shoulder Coil (System)	93	FDA UDI	Class II	Active
Wireless Headphones	37	FDA UDI	Class II	Active
Technologist Console Interface	80	FDA UDI	Class II	Active
Sentinel P1 Audio Interface Module	76	FDA UDI	Class II	Active
GEM Flex Knee Stabilizer for Curved Tables	57	FDA UDI	Class II	Active
ECG CT Gating Device	31	FDA UDI	Class II	Active
Scan Room Module	78	FDA UDI	Class II	Active
14 x 4 x 2 wedge pad	50	FDA UDI	Class II	Active
Flex Coils Pediatric Stabilizer	26	FDA UDI	Class II	Active
8 x 3 x 0.5 pad	49	FDA UDI	Class II	Active
Siemens audio module	73	FDA UDI	Class II	Active
Communication Control	22	FDA UDI	Class II	Active
Sentinel S2 Audio Interface	75	FDA UDI	Class II	Active
Tech Console	36	FDA UDI	Class II	Active
Drape Pack, Biopsy, Breast Coil	52	FDA UDI	Class II	Active
1.5T 16‐Channel Flex Coils for Siemens, Small	43	FDA UDI	Class II	Active
3T 6CH Carotid Coil	01	FDA UDI	Class II	Active
General Purpose Support pad	64	FDA UDI	Class II	Active
1.5T 16ch Breast Coil	46	FDA UDI	Class II	Active
Biopsy Grid Assembly, Pack, Breast Coil	51	FDA UDI	Class II	Active
Battery Charger	40	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.