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ATOS MEDICAL INC.

Last updated May 27, 2026

What ATOS MEDICAL INC. makes

Atos Medical Inc. manufactures tracheostomy-related devices, including non-reinforced, reusable tracheostomy tubes, tracheoesophageal speech valves for indwelling use, tracheostoma protective filters, and removable ambulatory skin-adherent patches. Their portfolio also covers tracheostomy tube neck holders (single-use), airway cleaning utensils (noninvasive, reusable), tracheostoma buttons, and accessories like shower shields. Additional products include adhesive solutions, dilators, and heat and moisture exchangers (HMEs) for tracheostomy care.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. 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: US
Address: —
Website: atosmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-217-0025
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 008224748

Catalogue (460)

Page 5 of 10

Device	Model / Reference	Registries	Class	Status
Provox Life Night Adhesive	8261	FDA UDI	Class I	Active
Provox XtraBase (3pcs)	8233	FDA UDI	Class I	Unknown
Provox® Vega™	17 Fr	FDA UDI	Class II	Unknown
Provox Life LaryTube 10/36 Fenestrated with Ring	8052	FDA UDI	Class I	Active
Atos Medical	2010-064	FDA UDI	N/A	Unknown
Atos Medical	10/36	FDA UDI	N/A	Unknown
Provox Vega 17Fr 4mm	8270	FDA UDI	Class II	Active
Provox OptiDerm Plus (3pcs)	8239	FDA UDI	Class I	Unknown
Provox LaryTube 8/55 with Ring	7625	FDA UDI	Class I	Active
Atos Medical	2010-063	FDA UDI	N/A	Unknown
Provox TwistLock 20Fr	8031	FDA UDI	Class I	Active
Provox Vega Plug 17	8119	FDA UDI	Class II	Active
Provox Vega Puncture Set 20Fr 12.5mm	8146US	FDA UDI	Class II	Active
Provox FlexiDerm Plus (3pcs)	8238	FDA UDI	Class I	Unknown
Provox ActiValve Light 8 mm	7152	FDA UDI	Class II	Active
Provox Vega XtraSeal 22.5Fr 10mm	8303	FDA UDI	Class II	Active
Provox2 Voice Prosthesis 4.5mm	7216	FDA UDI	Class II	Active
Atos Medical	2010-069	FDA UDI	N/A	Unknown
Freevent XtraCare Mini White (30 pcs)	8004	FDA UDI	Class I	Active
Provox LaryTube 9/55, Fenestrated	7641	FDA UDI	Class I	Active
Provox Life LP Kit 16 - LT 10/55-2HSTP	6145	FDA UDI	Class II	Active
Freevent XtraCare White (30 pcs)	7767	EUDAMEDFDA UDI	Class I	Active
Freevent XtraCare Mini Pink (30 pcs)	8006	FDA UDI	Class I	Active
Atos Medical	9/36	FDA UDI	N/A	Unknown
TheraBite ActiveBand Kit	8260	FDA UDI	Class I	Active
Atos Medical	9/27	FDA UDI	N/A	Unknown
Provox Vega 22.5Fr 12.5mm	8286	FDA UDI	Class II	Active
Provox Dilator 20	7123	FDA UDI	Class I	Active
Provox2 Voice Prosthesis 8mm	7218	FDA UDI	Class II	Active
Provox LaryButton 18/18	7688	FDA UDI	Class I	Active
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox Vega 22.5Fr 15mm	8287	FDA UDI	Class II	Active
Provox Life LP Kit 1 - LT 8/36, 8/55	6130	FDA UDI	Class II	Active
Provox LaryTube 12/36	7614	FDA UDI	Class I	Active
Atos Medical	12/55	FDA UDI	N/A	Unknown
Provox Tracheofix	1 strip ivory 70x70	FDA UDI	Class I	Unknown
Provox® Vega™ XtraSeal™	20 Fr	FDA UDI	Class II	Unknown
Provox Plug	7205	FDA UDI	Class II	Active
Atos Medical	8/55	FDA UDI	N/A	Unknown
Provox Life LaryTube 10/36 Standard	7416	FDA UDI	Class I	Active
Provox Adhesive FlexiDerm Plus	7331	FDA UDI	Class I	Active
Provox® Vega™	17 Fr	FDA UDI	Class II	Unknown
Atos Medical Inc	2010-073	FDA UDI	N/A	Unknown
Provox Vega Plug 20	8129	FDA UDI	Class II	Active
Provox® FreeHands HME® Replacement Device Light	7716	FDA UDI	Class II	Unknown
Provox Vega 17Fr 15mm	8275	FDA UDI	Class II	Active
Atos Medical	10/55	FDA UDI	N/A	Unknown
Freevent XtraCare Mini Blue (30 pcs)	8005	FDA UDI	Class I	Active
Atos Medical	2010-065	FDA UDI	N/A	Unknown
Freevent Neckband, two-piece, small	1752	FDA UDI	Class I	Unknown

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