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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 1 of 7

Device	Model / Reference	Registries	Class	Status
Precision Gold	13-10200-4015	FDA UDI	Class II	Active
Perfect Fit	18-01019-0301	FDA UDI	Class II	Active
Perfect Fit	11-30002-7502	FDA UDI	Class II	Active
Perfect Fit	18-01016-0601	FDA UDI	Class II	Active
TriplePlay	10-10000-0401	FDA UDI	Class II	Active
Perfect Fit	18-01017-0601	FDA UDI	Class II	Active
Perfect Fit	18-01019-0601	FDA UDI	Class II	Active
Perfect Fit	18-01807-0001	FDA UDI	Class II	Active
Perfect Fit	18-01806-0001	FDA UDI	Class II	Active
TriplePlay	12-40101-0001	FDA UDI	Class II	Active
Perfect Fit	18-01015-0301	FDA UDI	Class II	Active
Electrodes	13-30000-0001	FDA UDI	Class II	Active
Electrodes	13-41000-0001	FDA UDI	Class II	Active
Precision Gold	13-10100-6015	FDA UDI	Class II	Active
TriplePlay	10-10000-0501	FDA UDI	Class II	Active
Perfect Fit	18-01015-0601	FDA UDI	Class II	Active
Perfect Fit	18-01018-0301	FDA UDI	Class II	Active
TriplePlay	10-10000-0601	FDA UDI	Class II	Active
Electrodes	13-31000-0001	FDA UDI	Class II	Active
Electrodes	13-41001-0001	FDA UDI	Class II	Active
TriplePlay	10-10000-0301	FDA UDI	Class II	Active
Electrodes	13-40000-0001	FDA UDI	Class II	Active
Perfect Fit	18-01030-0001	FDA UDI	Class II	Active
Perfect Fit	11-30002-3002	FDA UDI	Class II	Active
Perfect Fit	11-30001-7502	FDA UDI	Class II	Active
Perfect Fit	18-14240-0602	FDA UDI	Class II	Active
Precision Gold	13-10200-1015	FDA UDI	Class II	Active
Perfect Fit	11-30001-3002	FDA UDI	Class II	Active
Electrodes	13-50000-0001	FDA UDI	Class II	Active
Precision Gold	13-10100-4015	FDA UDI	Class II	Active
Perfect Fit	18-01018-0601	FDA UDI	Class II	Active
Precision Gold	13-10200-6015	FDA UDI	Class II	Active
Perfect Fit	18-01016-0301	FDA UDI	Class II	Active
Precision Gold	13-10200-8015	FDA UDI	Class II	Active
Perfect Fit	18-01805-0001	FDA UDI	Class II	Active
TriplePlay	10-10000-0201	FDA UDI	Class II	Active
Precision Gold	13-10100-8015	FDA UDI	Class II	Active
TriplePlay	10-21001-0601	FDA UDI	Class II	Active
TriplePlay	12-30101-0001	FDA UDI	Class II	Active
Perfect Fit	18-01017-0301	FDA UDI	Class II	Active
Perfect Fit	18-01025-0601	FDA UDI	Class II	Active
Perfect Fit	18-01031-0001	FDA UDI	Class II	Active
Precision Gold	13-10100-1015	FDA UDI	Class II	Active
PerfectFit	11-42305-0601	EUDAMEDFDA UDI	Class I	Active
Snugglefit Effort Belt	12-42027-0001	EUDAMEDFDA UDI	Class I	Active
Perfect Fit 3D Effort Belt	11-45007-0001	EUDAMEDFDA UDI	Class I	Active
PerfectFit	18-12213-0302	EUDAMEDFDA UDI	Class I	Active
Perfect Fit 3D Effort Belt	11-45003-0001	EUDAMEDFDA UDI	Class I	Active
TriplePlay	10-14000-0401	EUDAMEDFDA UDI	Class I	Active
Perfect Fit 3D Effort Belt	11-45002-0001	EUDAMEDFDA UDI	Class I	Active

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