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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 7 of 10

Device	Model / Reference	Registries	Class	Status
Provox Insertion System 20Fr	8018	FDA UDI	Class I	Unknown
Provox LaryTube 10/36	7610	FDA UDI	Class I	Active
ProTrach® DualCare™ Speaking Valve Blue	7755	FDA UDI	Class II	Unknown
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox Brush Long	8404	FDA UDI	Class I	Active
Atos Medical	9/36	FDA UDI	N/A	Unknown
Provox ActiValve Light 10 mm	7153	FDA UDI	Class II	Active
Provox LaryTube 10/55 with Ring	7629	FDA UDI	Class I	Active
Freevent Neckband, two-piece, large	1762	EUDAMEDFDA UDI	Class I	Active
Provox Life LaryButton 16/8	8044	FDA UDI	Class I	Active
Provox Tracheofix	2 strip ivory 70x70	FDA UDI	Class I	Unknown
Provox® Vega™	20 Fr	FDA UDI	Class II	Unknown
Atos Medical	2010-059	FDA UDI	N/A	Unknown
Provox® Vega™	22.5 Fr	FDA UDI	Class II	Unknown
Atos Medical	9/36	FDA UDI	N/A	Unknown
Provox FreeHands FlexiVoice XtraStrong	8166	FDA UDI	Class II	Active
Provox® Vega™	20 Fr	FDA UDI	Class II	Unknown
ProTrach® HME 15 XtraMoist	7766	FDA UDI	Class II	Unknown
Atos Medical	2010-066	FDA UDI	N/A	Unknown
Provox Vega 22.5Fr 8mm	8284	FDA UDI	Class II	Active
ProTrach® HME 15 Regular	7742	FDA UDI	Class II	Unknown
Provox Life Go HME	8310	EUDAMEDFDA UDI	Class I	Active
Provox Vega 17Fr 6mm	8271	FDA UDI	Class II	Active
Provox XtraFlange 20	7276	FDA UDI	Class II	Active
Provox LaryTube 12/27	7613	FDA UDI	Class I	Active
Provox Life LaryTube 8/36 Fenestrated	7429	FDA UDI	Class I	Active
Freevent O2 Adaptor (10 pcs)	7769	FDA UDI	Class I	Active
Provox Life LaryTube 8/55 Fenestrated	7430	FDA UDI	Class I	Active
Provox Vega XtraSeal 22.5Fr 8mm	8302	FDA UDI	Class II	Active
Provox Life LaryTube 8/27 Standard	7409	FDA UDI	Class I	Active
Atos Medical	2010-13	FDA UDI	N/A	Unknown
Provox Vega XtraSeal 20Fr 4mm	8294	FDA UDI	Class II	Active
Provox Vega 20Fr 8mm	8278	FDA UDI	Class II	Active
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox Vega XtraSeal 17Fr 8mm	8290	FDA UDI	Class II	Active
Atos Medical	2010C-02	FDA UDI	N/A	Unknown
Provox LaryTube 8/36 with Ring	7624	FDA UDI	Class I	Active
Provox Life Day & Night EXP Stability	8064	EUDAMEDFDA UDI	Class I	Active
Provox Brush Long XL	8425	FDA UDI	Class I	Active
Provox Life LP Kit 8 - LT 12/36, 12/55	6137	FDA UDI	Class II	Active
Provox Life Night HME Experience	8072	EUDAMEDFDA UDI	Class I	Active
Provox LaryButton 12/8	7671	FDA UDI	Class I	Active
Provox® Vega™	17 Fr	FDA UDI	Class II	Unknown
Provox Vega XtraSeal 17Fr 15mm	8293	FDA UDI	Class II	Active
Provox® FreeHands HME® Flow	Flow	FDA UDI	Class II	Unknown
Provox® FreeHands HME® Moist	Moist	FDA UDI	Class II	Unknown
Atos Medical	10/55	FDA UDI	N/A	Unknown
Provox Life LaryButton 12/8	8040	FDA UDI	Class I	Active
Provox Adhesive OptiDerm Oval	7256	EUDAMEDFDA UDI	Class I	Active
Provox StabiliBase (3 pcs)	7299	FDA UDI	Class I	Active

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