FDA Registration
Active
🇸🇪 Sweden
ATOS MEDICAL AB
Reg #: 8032044
·
FEI: 3002806269
·
Expires 2026
Products
17
Proprietary Names
231
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- ATOS MEDICAL AB
- Registration Number
- 8032044
- FEI Number
- 3002806269
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- KRAFTGATAN 8
- City
- HORBY Skane
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K092593
Owner / Operator
- Firm Name
- ATOS MEDICAL AB
- Operator Number
- 8032044
- Address
- KRAFTGATAN 8, --
- City
- HORBY
- State
- SE-NOTA
- Postal Code
- SE-24235
- Country
- SE
- Correspondent
- Karolina - Nilsson
US Agent
- Business Name
- COLOPLAST CORP.
- Contact Name
- Jason Woehrle
- Address
- 1601 West River Road N
- City
- Minneapolis
- State
- MN
- ZIP
- 55411
- Country
- US
- [email protected]
- Phone
- 612 7302063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Laryngeal (Taub) | EWL | Class 2 | Ear, Nose, Throat | No | 2011-03-10 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2016-09-26 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 2006-09-22 |
| Tracheostomy Kit | OGW | Class 2 | Anesthesiology | No | 2010-01-13 |
| Brush, Cleaning, Tracheal Tube | EPE | Class 1 | Anesthesiology | No | 1999-05-07 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 1999-06-08 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2016-09-26 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 1999-05-07 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2019-01-28 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 1997-01-09 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2025-09-05 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 1999-05-07 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2016-02-26 |
| Prosthesis, Adhesive, External | GBJ | Class 1 | General, Plastic Surgery | No | 2002-10-11 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2003-04-11 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 1999-06-08 |
| Larynx, Artificial (Battery-Powered) | ESE | Class 1 | Ear, Nose, Throat | No | 2021-07-01 |
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
TheraBite Jaw Motion Rehabilitation
TheraBite Range of Motion Scale
TheraBite ActiveBand Kit
Therabite Bite Pad
Provox NID
Provox Guide Wire
Provox Vega Plug
Provox Plug
Provox Adhesive OptiDerm Plus
Provox Adhesive FlexiDerm Plus
Provox XtraBase Adhesive
Provox StabiliBase OptiDerm
Provox OptiDerm Oval
Provox Adhesive Strip
Provox FreeHands Support Adhesive
Provox FlexiDerm Oval
Provox Luna Adhesive
Provox Life Sensitive Adhesive Round
Provox Life Standard Adhesive Round
Provox Life Standard Adhesive Oval
Provox Life Sensitive Adhesive Oval
Provox Life Sensitive Adhesive Plus
Provox Life Sensitive Adhesive Oval B
Provox Life Night Adhesive
Provox Life Standard Experience Oval
Provox Life Standard Adhesive Plus
Provox Life Stability Adhesive
Provox Adhesive OptiDerm Oval
Provox Life Standard Experience Round
Provox StabiliBase
Provox Adhesive FlexiDerm Oval
Provox Life Sensitive Experience Oval
Provox Life Sensitive Experience Round
Provox Adhesive FlexiDerm Round
Provox Adhesive OptiDerm Round
Provox Life Night Adhesive Experience
Provox Life Stability Experience
Provox Life Sensitive Experience Plus
Provox Life Standard Experience Plus
Provox Life Adhesive Collection
Provox Life Comfort Experience Oval
Provox Life Comfort Adhesive Oval
Provox TruTone Emote
Provox SolaTone Plus
Provox TruTone Plus
Establishment Types
Manufacture Medical Device