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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 8 of 10

Device	Model / Reference	Registries	Class	Status
Provox GuideWire	7215	FDA UDI	Class II	Active
Atos Medical	2010-070	FDA UDI	N/A	Unknown
Provox® Vega™ XtraSeal™	22.5 Fr	FDA UDI	Class II	Unknown
Provox® Vega™	17 Fr	FDA UDI	Class II	Unknown
Provox Life LaryTube 8/36 Standard	7410	FDA UDI	Class I	Active
Atos Medical	9/36	FDA UDI	N/A	Unknown
Provox® Vega™	22.5 Fr	FDA UDI	Class II	Unknown
Provox LaryTube 10/55	7611	FDA UDI	Class I	Active
Atos Medical	2010-02E1	FDA UDI	N/A	Unknown
Atos Medical	2010-061	FDA UDI	N/A	Unknown
Provox Vega Plug 22.5	8139	FDA UDI	Class II	Active
Provox FreeHands FlexiVoice Medium	8162	EUDAMEDFDA UDI	Class II	Active
Provox Life LP Kit 12 - LT 12/36, 12/55	6141	FDA UDI	Class II	Active
Provox LaryTube 10/55, Fenestrated	7644	FDA UDI	Class I	Active
Atos Medical	12/55	FDA UDI	N/A	Unknown
Provox LaryTube 10/36, Fenestrated	7643	FDA UDI	Class I	Active
Provox Vega Puncture Set 17Fr 15mm	8143US	FDA UDI	Class II	Active
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox Life LaryTube 12/55 Fenestrated with Ring	8055	FDA UDI	Class I	Active
Provox XtraFlow HME (30 pcs)	7291	FDA UDI	Class I	Active
Atos Medical	9/36	FDA UDI	N/A	Unknown
TrachPhone (50 pcs)	7704	FDA UDI	Class I	Active
Provox® FreeHands HME® Speech Valve Membrane Medium	Medium	FDA UDI	Class II	Unknown
Freevent Neckband, two-piece, small	1652	FDA UDI	Class I	Active
Provox Life Sensitive Adhesive Oval B	7465	FDA UDI	Class I	Active
Atos Medical	12/55	FDA UDI	N/A	Unknown
Provox2 Voice Prosthesis 6mm	7217	FDA UDI	Class II	Active
Provox ActiValve XtraStrong 10 mm	7168	FDA UDI	Class II	Active
Provox LaryTube 8/36, Fenestrated	7637	FDA UDI	Class I	Active
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox Life LaryTube 12/36 Standard	7419	FDA UDI	Class I	Active
Provox Vega 20Fr 4mm	8276	FDA UDI	Class II	Active
Provox Vega XtraSeal 22.5Fr 12.5mm	8304	FDA UDI	Class II	Active
Atos Medical	2010-060	FDA UDI	N/A	Unknown
Provox Life Coming Home USA	8224US21	FDA UDI	Class I	Active
Provox Capsule 20Fr	7796	FDA UDI	Class I	Active
Atos Medical	10/55	FDA UDI	N/A	Unknown
Provox Vega 17Fr 12.5mm	8274	FDA UDI	Class II	Active
Atos Medical	2010-062	FDA UDI	N/A	Unknown
Provox Life Energy HME	8312	FDA UDI	Class I	Active
Provox Vega Puncture Set 22.5Fr 10mm	8148US	FDA UDI	Class II	Active
Provox FreeHands FlexiVoice Set Plus	7757	FDA UDI	Class II	Active
Provox Vega 22.5Fr 10mm	8285	FDA UDI	Class II	Active
Provox Tracheofix	1 strip beige 55x60	EUDAMEDFDA UDI	Class I	Active
Provox® Vega™ XtraSeal™	17 Fr	FDA UDI	Class II	Unknown
Provox FreeHands FlexiVoice Strong	8163	EUDAMEDFDA UDI	Class II	Active
ProTrach® DualCare™ Set 15	7741	FDA UDI	Class II	Unknown
Provox Life LaryTube 10/55 Fenestrated	7434	FDA UDI	Class I	Active
Provox ActiValve Lubricant	7149	FDA UDI	Class II	Active
HME DigiTop O2	7756	FDA UDI	Class I	Active

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