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Dymedix Diagnostics, Inc.

United States·US-MF-000015691

Last updated September 18, 2026

About

For Over 15 Years Dymedix Diagnostics Has Developed & Manufactured Physiological Sensors For The Sleep Medicine and Neurodiagnostic Community Of Technologists, Physicians & Patients. Click To Learn More!

From the manufacturer's own website. Source

What Dymedix Diagnostics, Inc. makes

Dymedix Diagnostics, Inc. manufactures polysomnography systems and single-use analytical scalp electrodes designed for sleep medicine and neurodiagnostic applications. Their product line includes reusable polysomnographs like the Precision Gold and TriplePlay, alongside disposable electrodes branded as Perfect Fit. These devices are intended for monitoring physiological signals during sleep studies and clinical diagnostics.

The company’s products are regulated under FDA’s Class I and Class II categories, with some devices listed in the FDA’s 510(k) and UDI registries. They are also included in the EU’s eudamed database, reflecting their availability in both US and European markets. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 5985, Rice Creek Parkway, Shoreview, United States
Website: www.dymedix.com
LinkedIn: —
Facebook: facebook.com/Dymedix
Email: [email protected]
Phone: 763-789-8280
PRRC Contact: Alan VanHouten
EUDAMED SRN: US-MF-000015691
FDA FEI Number: —
DUNS Number: 079976463

Catalogue (339)

Page 2 of 7

Device	Model / Reference	Registries	Class	Status
Perfect Fit	11-22200-0301	EUDAMEDFDA UDI	Class I	Active
PerfectFit	11-43300-4501	EUDAMEDFDA UDI	Class I	Active
PerfectFit	18-12214-0302	EUDAMEDFDA UDI	Class I	Active
Perfect Fit 3D Effort Belt	11-45006-0001	EUDAMEDFDA UDI	Class I	Active
PerfectFit	11-23300-3502	EUDAMEDFDA UDI	Class I	Active
FastTrack Effort Belt	18-01800-0001	EUDAMEDFDA UDI	Class I	Active
FastTrack Effort Belt	11-44200-7550	EUDAMED	Class I	Active
PerfectFit	18-14216-0602	EUDAMEDFDA UDI	Class I	Active
TriplePlay	12-10113-0001	EUDAMEDFDA UDI	Class I	Active
FastTrack Effort Belt	12-42012-0001	EUDAMEDFDA UDI	Class I	Active
TriplePlay	12-40210-0001	EUDAMEDFDA UDI	Class I	Active
FastTrack Effort Belt	18-01801-0001	EUDAMEDFDA UDI	Class I	Active
FastTrack Effort Belt	12-42016-0001	EUDAMEDFDA UDI	Class I	Active
PerfectFit	11-94320-0601	EUDAMEDFDA UDI	Class I	Active
Snugglefit Effort Belt	11-14002-1001	EUDAMEDFDA UDI	Class I	Active
TriplePlay	12-40200-0001	EUDAMEDFDA UDI	Class I	Active
TriplePlay	12-40304-0001	EUDAMEDFDA UDI	Class I	Active
EMG Surface Electrodes	13-14000-1020	EUDAMED	Class I	Active
PerfectFit	12-42002-0001	EUDAMEDFDA UDI	Class I	Active
Accusnore	12-20020-0001	EUDAMEDFDA UDI	Class I	Active
PerfectFit	18-14210-0602	EUDAMEDFDA UDI	Class I	Active
FastTrack Effort Belt	12-42014-0001	EUDAMEDFDA UDI	Class I	Active
EMG Surface Electrodes	13-14000-4802	EUDAMEDFDA UDI	Class I	Active
PerfectFit	11-42710-0601	EUDAMEDFDA UDI	Class I	Active
PerfectFit	12-41203-0301	EUDAMEDFDA UDI	Class I	Active
PerfectFit	18-12211-0302	EUDAMEDFDA UDI	Class I	Active
TriplePlay	10-10000-0650	EUDAMED	Class I	Active
TriplePlay	12-10003-0001	EUDAMEDFDA UDI	Class I	Active
PerfectFit	11-23300-1502	EUDAMEDFDA UDI	Class I	Active
Perfect Fit 3D Effort Belt	11-14001-5001	EUDAMEDFDA UDI	Class I	Active
TriplePlay	19-20000-0001	EUDAMEDFDA UDI	Class I	Active
PerfectFit	11-22700-0301	EUDAMEDFDA UDI	Class I	Active
PerfectFit	12-42000-0001	EUDAMEDFDA UDI	Class I	Active
Accusnore	12-20004-0001	EUDAMEDFDA UDI	Class I	Active
FastTrack Effort Belt	12-41114-0001	EUDAMEDFDA UDI	Class I	Active
TriplePlay	12-10017-0001	EUDAMEDFDA UDI	Class I	Active
FastTrack Effort Belt	18-14250-0601	EUDAMEDFDA UDI	Class I	Active
TriplePlay	12-40203-0001	EUDAMEDFDA UDI	Class I	Active
PerfectFit	11-42303-0601	EUDAMEDFDA UDI	Class I	Active
PerfectFit	11-94220-0602	EUDAMEDFDA UDI	Class I	Active
Snugglefit Effort Belt	11-15000-0010	EUDAMEDFDA UDI	Class I	Active
PerfectFit	18-14211-0602	EUDAMEDFDA UDI	Class I	Active
FastTrack Effort Belt	18-01802-0001	EUDAMEDFDA UDI	Class I	Active
PerfectFit	11-22406-0301	EUDAMEDFDA UDI	Class I	Active
TriplePlay	12-10116-0001	EUDAMEDFDA UDI	Class I	Active
PerfectFit	11-22303-0301	EUDAMEDFDA UDI	Class I	Active
Perfect Fit 3D Effort Belt	11-45003-0002	EUDAMEDFDA UDI	Class I	Active
FastTrack Effort Belt	12-42011-0001	EUDAMEDFDA UDI	Class I	Active
Rubicon SA System	K200654	FDA 510(k)	Class II	Active
Disposable Gold Cup EEG Electrodes	K192564	FDA 510(k)	Class II	Active

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