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NIKOMED USA INC

United States·US-MF-000026969

Last updated June 8, 2026

Information

Country: United States
Address: 2800, Turnpike Drive, Hatboro, United States
Website: nikomedusa.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Mo Perera
EUDAMED SRN: US-MF-000026969
FDA FEI Number: —
DUNS Number: —

Catalogue (67)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Disposable Ecg Monitoring Electrode #4110 45mm, #4140 35mm	K950472	FDA 510(k)	Class II	Active
Nikopad Electrosurgical Grounding Pad, Model 4777m	K000079	FDA 510(k)	Class II	Active
Disposable Ecg Monitoring Electrode #4570 38x60mm	K950478	FDA 510(k)	Class II	Active
49-610 Niko-Nose Fixation Tape	K902896	FDA 510(k)	Class I	Active
Disposable Ecg Monitoring Electrode #4533 32x45mm	K950474	FDA 510(k)	Class II	Active
Disposable Ecg Monitoring Electrode #4530, #4540	K950475	FDA 510(k)	Class II	Active
Disposable Ecg Monitoring Electrode #4535 32x45mm	K950470	FDA 510(k)	Class II	Active
Disposable Ecg Monitoring Electrode #4539 28x45mm	K950480	FDA 510(k)	Class II	Active
Dp-700 Nikman Defib-Pads	K872793	FDA 510(k)	Class II	Active
Disposable Ecg Monitoring Electrode #4440 60mm, #4420 40mm	K950476	FDA 510(k)	Class II	Active
Nikomed Trace 1 Ecg Electrodes	K022909	FDA 510(k)	Class II	Active
Disposable Ecg Monitoring Electrode #4580 32x45mm	K950471	FDA 510(k)	Class II	Active
Disposable Ecg Monitoring Electrode #4560 38x60mm	K950477	FDA 510(k)	Class II	Active
Disposable Ecg Monitoring Electrode #4600 60mm, #4610 45mm	K950479	FDA 510(k)	Class II	Active
Disposable Ecg Monitoring Electrode	K950473	FDA 510(k)	Class II	Active
NikoClips	NIK-20	EUDAMEDFDA UDI	Class I	Active
NikoClips	NIK-20W	EUDAMEDFDA UDI	Class I	Active

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