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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 4 of 10

Device	Model / Reference	Registries	Class	Status
Provox NID 17, 8 mm	7102	FDA UDI	Class II	Active
Provox ActiValve XtraStrong 4.5 mm	7165	FDA UDI	Class II	Active
Provox NID 20, 12 mm	7114	FDA UDI	Class II	Active
Provox® Vega™	22.5 Fr	FDA UDI	Class II	Unknown
Provox® Vega™	17 Fr	FDA UDI	Class II	Unknown
Provox NID 17, 18 mm	7106	FDA UDI	Class II	Active
Atos Medical	7256	FDA UDI	N/A	Unknown
Atos Medical	10/55	FDA UDI	N/A	Unknown
Provox LaryButton 18/8	7674	FDA UDI	Class I	Active
Provox FreeHands FlexiVoice Arch (5 pcs)	8165	EUDAMEDFDA UDI	Class II	Active
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox Life LaryTube 12/36 Fenestrated	7435	FDA UDI	Class I	Active
Provox Life Standard Experience Oval	8066	FDA UDI	Class I	Active
Atos Medical	12/36	FDA UDI	N/A	Unknown
Provox LaryTube 12/36, Fenestrated	7646	FDA UDI	Class I	Active
Atos Medical	10/36	FDA UDI	N/A	Unknown
Provox ActiValve Strong 8 mm	7162	FDA UDI	Class II	Active
Atos Medical	10/55	FDA UDI	N/A	Unknown
Atos Medical	2010-074	FDA UDI	N/A	Unknown
Provox Life LaryTube 10/36 Standard with Ring	7425	FDA UDI	Class I	Active
Provox LaryTube 12/55	7615	FDA UDI	Class I	Active
Provox FreeHands FlexiVoice Light	8161	EUDAMEDFDA UDI	Class II	Active
Provox Life LaryTube 9/36 Standard with Ring	7423	FDA UDI	Class I	Active
Provox Life Night Adhesive Experience	8075	FDA UDI	Class I	Active
Atos Medical	9/55	FDA UDI	N/A	Unknown
Provox® FreeHands HME® Replacement Device Medium	Medium	FDA UDI	Class II	Unknown
Provox LaryTube 9/36 with Ring	7626	FDA UDI	Class I	Active
Provox LaryTube 9/36	7606	FDA UDI	Class I	Active
Provox LaryTube 12/36 with Ring	7630	FDA UDI	Class I	Active
Provox Brush XL	7225	FDA UDI	Class I	Active
Provox ActiValve Light 12.5 mm	7154	FDA UDI	Class II	Active
Atos Medical	09/36	FDA UDI	N/A	Unknown
Provox LaryTube 10/27	7609	FDA UDI	Class I	Active
Provox® FreeHands HME® Cleaning and Storage Box	7718	FDA UDI	Class II	Unknown
Provox Vega 17Fr 8mm	8272	FDA UDI	Class II	Active
Provox Life LP Kit 6 - LT 9/36, 9/55	6135	FDA UDI	Class II	Active
Atos Medical	10/55	FDA UDI	N/A	Unknown
Provox LaryTube 8/55, Fenestrated	7638	FDA UDI	Class I	Active
Atos Medical	10/55	FDA UDI	N/A	Unknown
Provox OptiDerm Round (3pcs)	8236	FDA UDI	Class I	Unknown
Freevent XtraCare Blue (5 pcs)	7788	EUDAMEDFDA UDI	Class I	Active
Provox Life LP Kit 3 - LT 10/36, 10/55	6132	FDA UDI	Class II	Active
Provox Life LP Kit 13 - LT 9/55	6142	FDA UDI	Class II	Active
Provox® Vega™ XtraSeal™	17 Fr	FDA UDI	Class II	Unknown
Provox Vega 17Fr 10mm	8273	FDA UDI	Class II	Active
Atos Medical	2010C4-02	FDA UDI	N/A	Unknown
Provox FreeHands FlexiVoice Set	7760	FDA UDI	Class II	Active
Provox Life LaryTube 10/27 Standard	7415	FDA UDI	Class I	Active
Provox Adhesive OptiDerm Round	7255	EUDAMEDFDA UDI	Class I	Active
Provox® Vega™	20 Fr	FDA UDI	Class II	Unknown

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