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 | |
|---|---|---|---|
| 07331791016905 | 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 |
| 07331791181153 | Provox Life Oxygen (10 pcs) - 7620 | +4641519800 | info@atosmedical.com |
| 07331791181160 | Provox Life Oxygen (30 pcs) - 7621 | +4641519800 | info@atosmedical.com |
| 07331791181177 | Provox Dilator 17 - 8342 | +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
Provox Life Comfort Adhesive Oval - 8403
2026-01-16
Provox Life Comfort Experience Oval - 8094
2026-01-16
Provox Life Oxygen (10 pcs) - 7620
2025-12-16
Provox Life Oxygen (30 pcs) - 7621
2025-12-16
Provox Dilator 17 - 8342
2025-07-01
Provox Dilator 20 - 8343
2025-07-01
Provox Dilator - 8341
2025-02-08
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 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 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 Life Go HME - Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
2022-12-07
Provox Life Home HME - Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
2022-12-07
Provox Life Energy HME - Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
2022-12-07
Provox Life Protect HME - Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
2022-12-07
Freevent XtraCare Mini Blue (30 pcs) - Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma.
2023-12-04
Freevent XtraCare Mini Pink (30 pcs) - Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma.
2023-12-04
Freevent XtraCare Mini White (5 pcs) - Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma.
2023-12-04
Freevent O2 Adaptor Mini (10 pcs) - Freevent O2 Adaptor Mini is a single use accessory used together with Freevent XtraCare Mini. The device is intended to enable additional oxygen supply for patients breathing through a tracheostoma during use of Freevent XtraCare Mini.
2023-12-04
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 Night HME Experience - Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma
2022-12-05
Provox Life Energy HME Experience - Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma
2022-12-05
Provox Life Protect HME Experience - Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma
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 Home HME Experience - Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
2024-06-21
Provox Life Go HME Experience - Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
2024-06-21
Freevent XtraCare Mini White - Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma.
2023-12-04
Provox StabiliBase (3pcs) - 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 (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 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
Provox OptiDerm Oval (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 Plus (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