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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 3 of 10

Device	Model / Reference	Registries	Class	Status
Provox® FreeHands HME® Casette	7712	FDA UDI	Class II	Unknown
Provox Life Day & Night Experience Oval	8061	EUDAMEDFDA UDI	Class I	Active
Provox® Vega™ XtraSeal™	17 Fr	FDA UDI	Class II	Unknown
Provox® FreeHands HME® Speech Valve Membrane Light	Light	FDA UDI	Class II	Unknown
Provox Vega 20Fr 12.5mm	8280	FDA UDI	Class II	Active
Provox Insertion System 17Fr	8017	FDA UDI	Class I	Unknown
Provox Coming Home USA	8224US	FDA UDI	Class I	Unknown
Freevent O2 Adaptor Mini (10 pcs)	8007	FDA UDI	Class I	Active
Atos Medical	10/36	FDA UDI	N/A	Unknown
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox ActiValve Strong 4.5 mm	7160	FDA UDI	Class II	Active
Atos Medical	9/55	FDA UDI	N/A	Unknown
Atos Medical	10/55	FDA UDI	N/A	Unknown
Provox Life LaryButton 18/18	8047	FDA UDI	Class I	Active
Provox Life LaryTube 9/55 Standard	7414	FDA UDI	Class I	Active
Provox® Vega™	20 Fr	FDA UDI	Class II	Unknown
Provox Dilator 17	8342	EUDAMEDFDA UDI	Class I	Active
Provox NID 20, 6 mm	7111	FDA UDI	Class II	Active
Provox Life Standard Experience Round	8065	FDA UDI	Class I	Active
Provox Adhesive OptiDerm Plus	7332	EUDAMEDFDA UDI	Class I	Active
Provox Life Sensitive Experience Plus	8070	FDA UDI	Class I	Active
Atos Medical	10/55	FDA UDI	N/A	Unknown
Provox Tracheofix	2 strips beige 55x60	EUDAMEDFDA UDI	Class I	Active
Atos Medical	2010-071	FDA UDI	N/A	Unknown
Atos Medical	00	FDA UDI	N/A	Unknown
Provox Vega XtraSeal 20Fr 10mm	8297	FDA UDI	Class II	Active
Provox Life Stability Adhesive	8263	FDA UDI	Class I	Active
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox Life LaryTube 9/27 Standard	7412	FDA UDI	Class I	Active
Provox Vega XtraSeal 20Fr 15mm	8299	FDA UDI	Class II	Active
Provox ActiValve XtraStrong 12.5 mm	7169	FDA UDI	Class II	Active
Atos Medical	10/36	FDA UDI	N/A	Unknown
Provox ActiValve XtraStrong 6 mm	7166	FDA UDI	Class II	Active
Provox Life LP Kit 11- LT 10/36, 10/55	6140	FDA UDI	Class II	Active
Atos Medical	10/55	FDA UDI	N/A	Unknown
Provox Vega XtraSeal 22.5Fr 6mm	8301	FDA UDI	Class II	Active
Freevent DualCare Speaking Valve Blue	7755	FDA UDI	Class II	Active
Atos Medical Inc	2010-076	FDA UDI	N/A	Unknown
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox Life LaryTube 12/36 Standard with Ring	7427	FDA UDI	Class I	Active
Provox Life Day & Night Experience Round	8060	EUDAMEDFDA UDI	Class I	Active
Provox® Vega™ XtraSeal™	17 Fr	FDA UDI	Class II	Unknown
Atos Medical	9/36	FDA UDI	N/A	Unknown
Provox XtraMoist HME (30 pcs)	7290	FDA UDI	Class I	Active
Provox LaryTube 12/55, Fenestrated	7647	FDA UDI	Class I	Active
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox NID 20, 10 mm	7113	FDA UDI	Class II	Active
Provox Life Sensitive Experience Oval	8069	FDA UDI	Class I	Active
Provox Vega XtraSeal 20Fr 6mm	8295	FDA UDI	Class II	Active
Atos Medical	10/55	FDA UDI	N/A	Unknown

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