atosmedical.comProTrach Dualcare
ATOS MEDICAL AB
ATOS MEDICAL AB
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8032044 | 3002806269 | ATOS MEDICAL AB | 1 | N | 2026-01-01 | KRAFTGATAN 8 HORBY Skane SE SE-24235 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07331791001611 | Provox Adhesive FlexiDerm Round - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. | +4641519800 | info@atosmedical.com |
| 07331791001628 | Provox Adhesive FlexiDerm Oval - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. | +4641519800 | info@atosmedical.com |
| 07331791001635 | Provox Adhesive OptiDerm Round - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. | +4641519800 | info@atosmedical.com |
| 07331791001642 | Provox Adhesive OptiDerm Oval - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. | +4641519800 | info@atosmedical.com |
| 07331791001703 | Provox XtraBase Adhesive - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.The FlexiDerm adhesives are Provox FlexiDerm Round/Oval/Plus and Provox XtraBase with a concave shaped base. | +4641519800 | info@atosmedical.com |
| 07331791008016 | Provox StabiliBase (15 pcs) - Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. The design of the StabiliBase adapter can be especially suitable for deep tracheostomas. | +4641519800 | info@atosmedical.com |
| 07331791008320 | HME DigiTop O2 - The HME DigiTop O2 is an accessory to Freevent HMEs and Provox FreeHands HME's. For patients spontaneously breathing through a tracheostoma and having a need of extra oxygen. | +4641519800 | info@atosmedical.com |
| 07331791015564 | Provox Life Coming Home USA - Provox Coming Home/Provox Life Coming Home is an assortment of products and information for newly laryngectomized persons. It provides guidance on product use, lung rehabilitation, and stoma care at home. | +4641519800 | info@atosmedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 11026 | 1224448296 | K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM | EWL | 1997-06-06 |
| 11026 | 1511940733 | K940638 | PROVOX(TM) VOICE PROSTHESIS | EWL | 1994-06-22 |
| 11026 | 1443467494 | K151404 | ProTrach Dualcare | JOH | 2016-02-12 |
| 11026 | 1793078609 | K141380 | PROVOX FREEHANDS FLEXIVOICE | EWL | 2014-09-26 |
| 11026 | 1034847053 | K131947 | PROVOX VEGA PUNCTURE SET | EWL | 2013-10-18 |
| 11026 | 1858402626 | K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | EWL | 2010-10-14 |
| 11026 | 1871395635 | K090455 | PROVOX VEGA, MODEL 8130-8135 | EWL | 2009-06-05 |
| 11026 | 1167261760 | K072582 | PROVOX MICRON HME | JOH | 2008-05-30 |
| 11026 | 1831672724 | K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 | EWL | 2004-11-22 |
| 11026 | 2022265825 | K022125 | PROVOX FREEHANDS HME, MODEL 7710 | EWL | 2002-07-30 |
| 11026 | 1532947815 | K014102 | PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 | JOH | 2002-02-21 |
| 11026 | 1101603220 | ||||
| 11026 | 1027798751 | ||||
| 11026 | 1065048837 | ||||
| 11026 | 1074778555 | ||||
| 11026 | 1187230716 | ||||
| 11026 | 1260185809 | ||||
| 11026 | 1329033576 | ||||
| 11026 | 1369406381 | ||||
| 11026 | 1379302213 | ||||
| 11026 | 1399091899 | ||||
| 11026 | 1451964198 | ||||
| 11026 | 1505807949 | ||||
| 11026 | 1699504248 | ||||
| 11026 | 1797408170 | ||||
| 11026 | 1871815786 | ||||
| 11026 | 2040461320 |
Product Codes Associated With Registrations#
PMN#
PROVOX FREEHANDS FLEXIVOICE
ATOS MEDICAL AB
PROVOX VEGA PUNCTURE SET
ATOS MEDICAL AB
PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)
ATOS MEDICAL AB
PROVOX VEGA, MODEL 8130-8135
ATOS MEDICAL AB
PROVOX MICRON HME
ATOS MEDICAL AB
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
ATOS MEDICAL AB
PROVOX FREEHANDS HME, MODEL 7710
ATOS MEDICAL AB
PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
ATOS MEDICAL AB
PROVOX 2 VOICE PROSTHESIS SYSTEM
ATOS MEDICAL AB
SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
ATOS MEDICAL AB
PROVOX(TM) VOICE PROSTHESIS
ATOS MEDICAL AB
TYMPOVENT
ATOS MEDICAL AB
SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS
ATOS MEDICAL AB
SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM
ATOS MEDICAL AB
GUDID#
HME DigiTop O2 - The HME DigiTop O2 is an accessory to Freevent HMEs and Provox FreeHands HME's. For patients spontaneously breathing through a tracheostoma and having a need of extra oxygen.
2022-12-07
Provox Life Coming Home USA - Provox Coming Home/Provox Life Coming Home is an assortment of products and information for newly laryngectomized persons. It provides guidance on product use, lung rehabilitation, and stoma care at home.
2022-11-29
Provox Adhesive FlexiDerm Round - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.
2022-07-13
Provox Adhesive FlexiDerm Oval - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.
2022-07-13
Provox Adhesive OptiDerm Round - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.
2022-07-13
Provox Adhesive OptiDerm Oval - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.
2022-07-13
Provox XtraBase Adhesive - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.The FlexiDerm adhesives are Provox FlexiDerm Round/Oval/Plus and Provox XtraBase with a concave shaped base.
2022-07-13
Provox StabiliBase (15 pcs) - Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. The design of the StabiliBase adapter can be especially suitable for deep tracheostomas.
2022-07-13
Provox Adhesive FlexiDerm Plus - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.
2022-07-13
Provox Adhesive OptiDerm Plus - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.
2022-07-13
Provox StabiliBase OptiDerm (15 pcs) - Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. The design of the StabiliBase adapter can be especially suitable for deep tracheostomas.
2022-07-13
Provox Luna Adhesive - Provox Luna Adhesive is a skin-friendly, single use adhesive that provides attachment for the Provox Luna HME for night-time use after totallaryngectomy.
2022-07-13
Provox FreeHands Support Adhesive (15 pcs) - The Provox FreeHands Support system consists of two parts; Provox FreeHandsSupport and Provox FreeHands Support Adhesive.Provox FreeHands Support Adhesive is a single-use adhesive that is attached to the skin, beneath the Provox Adhesive.
2022-07-13
Provox Adhesive Strip - Provox Adhesive Strip is a single use device to seal Provox adhesives, e.g. during showering.
2022-07-13
Provox Life Standard Adhesive Round - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy.
2022-07-13
Provox Life Standard Adhesive Oval - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy.
2022-07-13
Provox Life Standard Adhesive Plus - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy.
2022-07-13
Provox Life Sensitive Adhesive Round - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy.Provox Life Sensitive Adhesives have an adhesive material with permanent skin contact that is hypoallergenic and suitable for sensitive skin.
2022-07-13
Provox Life Sensitive Adhesive Oval - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy.Provox Life Sensitive Adhesives have an adhesive material with permanent skin contact that is hypoallergenic and suitable for sensitive skin.
2022-07-13
Provox Life Sensitive Adhesive Oval B - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy.Provox Life Sensitive Adhesives have an adhesive material with permanent skin contact that is hypoallergenic and suitable for sensitive skin.
2022-07-13
Provox Life Sensitive Adhesive Plus - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy.Provox Life Sensitive Adhesives have an adhesive material with permanent skin contact that is hypoallergenic and suitable for sensitive skin.
2022-07-13
Provox Life Stability Adhesive - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy.
2022-07-13
Provox Life Night Adhesive - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy. Provox Life Night Adhesive have an adhesive material with permanent skin contact that is hypoallergenic and suitable for sensitive skin.
2022-07-13
Provox Life Standard Experience Round - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy
2022-11-29
Provox Life Standard Experience Oval - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy
2022-11-29
Provox Life Standard Experience Plus - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy
2022-12-05
Provox Life Sensitive Experience Round - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy
2022-11-29
Provox Life Sensitive Experience Oval - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy
2022-11-29
Provox Life Sensitive Experience Plus - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy
2022-12-05
Provox Life Stability Experience - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy
2022-12-05
Provox Life Night Adhesive Experience - Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy
2022-12-05
Provox Life Comfort Adhesive Oval - 8403
2026-01-16
Provox Life Adhesive Collection - 8095
2025-11-22
Provox Life Comfort Experience Oval - 8094
2026-01-16
Provox StabiliBase (3 pcs) - The Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.
2022-12-08
Provox StabiliBase OptiDerm (3pcs) - Provox StabiliBase OptiDerm adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.
2022-12-08
Provox XtraBase (3pcs) - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.
2022-12-08
Provox FlexiDerm Round (3pcs) - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.
2022-12-08
Provox FlexiDerm Oval (3 pcs) - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.
2022-12-08
Provox OptiDerm Round (3pcs) - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.
2022-12-08