ATOS MEDICAL AB

FDA Device Registration & Listing · HORBY Skane, SE · Registration 8032044

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8032044
FEI Number
3002806269
Entity Name
ATOS MEDICAL AB
City/State/Country
HORBY Skane, SE
Establishment Address
KRAFTGATAN 8, HORBY Skane SE-24235, SE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ATOS MEDICAL AB (Owner Number: 8032044)
Owner / Operator Contact Address
KRAFTGATAN 8, --, HORBY, SE-NOTA SE-24235, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Provox ActiValve ActiValve Lubricant Provox XtraFlange Removal Aid Provox LaryButton Sizer Kit Provox LaryTube Sizer Kit Provox Life LaryTube 12/55 Provox Life LaryTube 9/55 with Ring Provox Life LaryTube 9/36 Fenestrated with Ring Provox Life LaryTube 10/55 Provox Life LaryTube 8/27 Provox Life LaryTube 10/36 Fenestrated with Ring Provox Life LaryTube 8/55 Provox Life LaryTube 8/36 Fenestrated with Ring Provox Life LaryTube 10/36 Fenestrated Provox Life LaryTube 10/36 with Ring Provox Life LaryTube 9/55 Fenestrated Provox Life LaryTube 8/55 with Ring Provox Life LaryTube 9/55 Provox Life LaryTube 10/27 Provox Life LaryTube 12/36 Fenestrated Provox Life LaryTube 9/36 Provox Life LaryTube 10/55 with Ring Provox Life LaryTube 10/36 Provox Life LaryButton 12/8 Provox Life LaryTube 12/27 Provox Life LaryTube 12/55 with Ring Provox Life LaryTube 10/55 Fenestrated Provox Life LaryTube 9/27 Provox Life LaryTube 9/36 Fenestrated Provox Life LaryTube 8/36 Provox Life LaryTube 12/55 Fenestrated with Ring Provox Life LaryTube 9/36 with Ring Provox Life LaryButton 16/8 Provox Life LaryButton 18/18 Provox Life LaryTube 12/55 Fenestrated Provox Life LaryTube 10/55 Fenestrated with Ring Provox Life LaryButton 12/18 Provox Life LaryTube 12/36 Fenestrated with Ring Provox Life LaryTube 8/55 Fenestrated with Ring Provox Life LaryTube 8/36 with Ring Provox Life LaryButton 18/8 Provox Life LaryTube 12/36 Provox Life LaryTube 9/55 Fenestrated with Ring Provox Life LaryTube 8/55 Fenestrated Provox Life LaryButton 16/18 Provox Life LaryButton 14/8 Provox Life LaryTube 12/36 with Ring Provox Life LaryTube 8/36 Fenestrated Provox LaryTube Provox LaryButton Provox Life LaryButton 14/18 Provox Life LP Kit 8 - LT 12/36,12/55 Provox Life LP Kit 4 - LT 12/36,12/55 Provox Life LP Kit 10 - LT 9/36, 9/55 Provox Life LP Kit 3 - LT 10/36,10/55 Provox Life LP Kit 1 - LT 8/36, 8/55 Provox Life LP Kit 17 - LT 10/55-2HTTP Provox Life LP Kit 12 - LT 12/36,12/55 Provox Life LP Kit 6 - LT 9/36, 9/55 Provox Life LP Kit 7 - LT 10/36,10/55 Provox Life LP Kit 5 - LT 8/36, 8/55 Provox Life LP Kit 13 - LT 9/55 Provox Life LP Kit 11- LT 10/36,10/55 Provox Life LP Kit 16 - LT 10/55-2HSTP Provox Life LP Kit 2 - LT 9/36, 9/55 Provox Life LP Kit 9 - LT 8/36, 8/55 Provox Life LP Kit 15 - LT 10/55-2H Provox Life LP Kit 14 - LT 10/55 Provox TubeBrush Provox Swab XtraLarge Provox Swab Large Provox Swab Medium Provox Swab Small Provox Cleaning Towel Provox Adhesive Remover Provox2 Voice Prosthesis Freevent HME 22 Regular Freevent DualCare Set 22 Freevent DualCare Speaking Valve Blue Freevent HME 15 Regular Freevent DualCare Speaking Valve Freevent DualCare Set 15 Provox LaryClip Provox FreeHands Support Deep Provox FreeHands Support Flat Provox FreeHands Support Starter Set Provox FreeHands Support Medium Freevent Neckband, two-piece, small Freevent Neckband, two-piece, large Provox TubeHolder Freevent Connection Strap Provox Vega XtraSeal Provox Vega Provox FreeHands HME Flow Provox FreeHands FlexiVoice Set Provox FreeHands HME Moist Provox FreeHands FlexiVoice Medium Provox FreeHands FlexiVoice Light Provox FreeHands FlexiVoice Set Plus Provox FreeHands FlexiVoice Strong Provox FreeHands FlexiVoice Arch Provox FreeHands FlexiVoice XtraStrong Provox Life FreeHands FlexiVoice Set Plus Provox Vega Puncture Set 17Fr 10mm Provox Vega Puncture Set 20Fr 8mm Provox Vega Puncture Set 17Fr 8mm Provox Vega Puncture Set 17Fr 15mm Provox Vega Puncture Set 17Fr 12,5mm Provox Vega Puncture Set 20Fr 12,5mm Provox Vega Puncture Set 22,5Fr 12,5mm Provox Vega Puncture Set 20Fr 10mm Provox Vega Puncture Set 22,5Fr 8mm Provox Vega Puncture Set 22,5Fr 10mm Provox BasePlate Adaptor Provox Tracheofix 2 strips beige 70x70 Provox Tracheofix 2 strips beige 55x60 Provox Tracheofix 1 strip beige 55x60 Provox Tracheofix 1 strip beige 70x70 Provox Tracheofix 1 strip beige 38x63 Provox HME Cap Provox ShowerAid Provox HME Cassette Adaptor Provox Luna ShowerAid Provox Coming Home Canada Provox XtraFlow & XtraMoist HME HME DigiTop O2 Provox Luna HME Provox Luna Set Provox Life Go HME Provox Life Home HME Provox Life Shower Provox Life Energy HME TrachPhone (50 pcs) Freevent XtraCare White TrachPhone (30 pcs) Provox Life Protect HME Freevent O2 Adaptor (10 pcs) Provox Life Night HME Provox Life FreeHands HME Provox XtraMoist HME Freevent XtraCare Blue Provox Life Day & Night EXP Stability Provox Life Day & Night Experience Plus Provox Life Day & Night Experience Round Provox Life Day & Night Experience Oval Provox Life BasePlate Adaptor Provox Life Coming Home USA Provox Life Protect HME Experience Provox Life Energy HME Experience Provox XtraFlow HME Provox Life Night HME Experience Provox Life Day & Night EXP Sensitive TrachPhone (5 pcs) Freevent XtraCare Mini White 30 pcs Freevent XtraCare Mini Pink 30 pcs Freevent XtraCare Mini Blue 30 pcs Provox Life Go HME Experience Provox Life Oxygen (10 pcs) Freevent XtraCare Mini White 5 pcs Freevent O2 Adaptor Mini 10 pcs Provox Life Oxygen (30 pcs) Provox Life Home HME Experience Freevent Dressing Softfoam L Freevent Dressing Softfoam Slim Freevent Dressing Softfoam S Provox Measure Flanges Provox Capsule 22.5Fr Provox Capsule 17Fr Provox Capsule 20Fr Provox TwistLock 17Fr Provox TwistLock 22.5Fr Provox TwistLock 20Fr Provox Flush Provox Brush Long XL Stoma Sizing Guide Provox Brush Provox Brush XL Provox Brush Long Provox Dilator 20 (8343) Provox Dilator (8341) Provox Dilator 17 (8342) Provox Wipes Provox Skin Barrier Provox Micron HME Provox Silicone Glue

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EWL Prosthesis, Laryngeal (Taub) Ear, Nose, Throat Class 2 874.3730 2011-03-10
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2016-09-26
KAC Tube, Laryngectomy Ear, Nose, Throat Class 1 874.4420 2006-09-22
OGW Tracheostomy Kit Anesthesiology Class 2 868.5800 2010-01-13
EPE Brush, Cleaning, Tracheal Tube Anesthesiology Class 1 868.5795 1999-05-07
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 1999-06-08
EWL Prosthesis, Laryngeal (Taub) Ear, Nose, Throat Class 2 874.3730 2007-11-08
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2016-09-26
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 1999-05-07
EWL Prosthesis, Laryngeal (Taub) Ear, Nose, Throat Class 2 874.3730 2009-06-08
EWL Prosthesis, Laryngeal (Taub) Ear, Nose, Throat Class 2 874.3730 2014-10-29
EWL Prosthesis, Laryngeal (Taub) Ear, Nose, Throat Class 2 874.3730 2013-10-28
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2007-11-08
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2019-01-28
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 1997-01-09
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2025-09-05
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 1999-05-07
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2016-02-26
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2008-06-03
GBJ Prosthesis, Adhesive, External General, Plastic Surgery Class 1 878.3750 2002-10-11

Official Correspondent

Karolina Nilsson

US Agent Details

Jason Woehrle Business: COLOPLAST CORP. Email: usjawo@coloplast.com Phone: (612) 7302063

Related Public Records

Same Entity

ATOS MEDICAL AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K823749 Bivona Medical Technologies LOW PRESSURE BLOM-SINGER VOICE PROSTHES 1983-01-07
K142298 Covidien Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff 2015-02-13
K182861 Covidien Shiley Neonatal/Pediatric Tracheostomy Tube 2019-03-22
K142296 Covidien Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula 2015-02-24
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0044-2017 Teleflex Medical 2
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8032044. Last updated year: 2026. Please use registration number 8032044 when referencing this establishment in official correspondence.
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