Is this your brand? Sign in to claim ownership.

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 6 of 10

Device	Model / Reference	Registries	Class	Status
Provox Life Night HME	8262	FDA UDI	Class I	Active
Provox Life LaryTube 12/36 Fenestrated with Ring	8054	FDA UDI	Class I	Active
Atos Medical	2010-055	FDA UDI	N/A	Unknown
Provox Vega XtraSeal 17Fr 12.5mm	8292	FDA UDI	Class II	Active
Atos Medical	2010C2-44E6	FDA UDI	N/A	Unknown
Provox Vega 20Fr 10mm	8279	FDA UDI	Class II	Active
Provox® Vega™ XtraSeal™	20 Fr	FDA UDI	Class II	Unknown
Provox XtraFlange 22.5	7275	FDA UDI	Class II	Active
Removal Aid	7745	FDA UDI	Class I	Active
Provox Vega 20Fr 15mm	8281	FDA UDI	Class II	Active
Provox Life Home HME	8311	FDA UDI	Class I	Active
Provox ActiValve Light 4.5 mm	7150	FDA UDI	Class II	Active
Provox2 Voice Prosthesis 12.5mm	7221	FDA UDI	Class II	Active
Freevent XtraCare Mini White (5 pcs)	8008	EUDAMEDFDA UDI	Class I	Active
Provox Life LP Kit 17 - LT 10/55-2HTTP	6146	FDA UDI	Class II	Active
Atos Medical	2010-03E1	FDA UDI	N/A	Unknown
Provox ActiValve Light 6 mm	7151	FDA UDI	Class II	Active
Provox® FreeHands HME®	7710	FDA UDI	Class II	Unknown
Freevent HME 15 Regular	7742	EUDAMEDFDA UDI	Class II	Active
Provox Life Stability Experience	8071	FDA UDI	Class I	Active
Provox Tracheofix 2 strips beige 70x70	1433H	FDA UDI	Class I	Active
Provox Life LP Kit 5 - LT 8/36, 8/55	6134	FDA UDI	Class II	Active
Provox Life LaryButton 14/8	8042	FDA UDI	Class I	Active
Provox Life LaryTube 8/55 Standard	7411	FDA UDI	Class I	Active
Provox Life LaryTube 8/55 Fenestrated with Ring	8049	FDA UDI	Class I	Active
Provox Life Home HME Experience	8264	EUDAMEDFDA UDI	Class I	Active
Provox Life LP Kit 2 - LT 9/36, 9/55	6131	FDA UDI	Class II	Active
Provox LaryButton 16/18	7687	FDA UDI	Class I	Active
Provox TwistLock 22.5Fr	8032	EUDAMEDFDA UDI	Class I	Active
Provox Life Sensitive Adhesive Round	7463	FDA UDI	Class I	Active
Provox Vega Puncture Set 17Fr 12.5mm	8142US	FDA UDI	Class II	Active
ProTrach® DualCare™ Speaking Valve	7744	FDA UDI	Class II	Unknown
Provox® Vega™	22.5 Fr	FDA UDI	Class II	Unknown
Provox Life LaryTube 9/55 Fenestrated with Ring	8051	FDA UDI	Class I	Active
Provox SolaTone Plus	7438	FDA UDI	Class I	Active
Provox Life LaryTube 9/36 Standard	7413	FDA UDI	Class I	Active
Provox® Vega™ XtraSeal™	20 Fr	FDA UDI	Class II	Unknown
Provox Life LP Kit 15 - LT 10/55-2H	6144	FDA UDI	Class II	Active
Provox Vega 22.5Fr 4mm	8282	FDA UDI	Class II	Active
Atos Medical	10/55	FDA UDI	N/A	Unknown
Provox Vega XtraSeal 22.5Fr 4mm	8300	FDA UDI	Class II	Active
Provox® FreeHands HME® Speech Valve Membrane Strong	Strong	FDA UDI	Class II	Unknown
Provox® Vega™	20 Fr	FDA UDI	Class II	Unknown
Provox® FreeHands HME® Casette	7711	FDA UDI	Class II	Unknown
Provox Life LaryTube 10/55 Standard with Ring	7426	FDA UDI	Class I	Active
Atos Medical	2010-057	FDA UDI	N/A	Unknown
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox XtraFlow & XtraMoist HME (5+5pcs)	8229	FDA UDI	Class I	Active
Provox Life LaryButton 16/18	8045	FDA UDI	Class I	Active
Provox TubeHolder	7668	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.