FDA Registration
Active
🇨🇭 Switzerland
MEDELA AG
Reg #: 3002807523
·
FEI: 3002807523
·
Expires 2026
Products
13
Proprietary Names
79
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- MEDELA AG
- Registration Number
- 3002807523
- FEI Number
- 3002807523
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LAETTICHSTRASSE 4B
- City
- BAAR Zug
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K180415
Owner / Operator
- Firm Name
- MEDELA AG
- Operator Number
- 8030974
- Address
- LAETTICHSTRASSE 4b, --
- City
- BAAR
- State
- CH-NOTA
- Postal Code
- CH-6340
- Country
- CH
US Agent
- Business Name
- Medela LLC
- Contact Name
- Tim Karlovsky
- Address
- 1101 Corporate Dr.
- City
- McHenry
- State
- IL
- ZIP
- 60050
- Country
- US
- [email protected]
- Phone
- 815 3493708
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2018-11-13 |
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2006-09-21 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2013-03-26 |
| Extractor, Vacuum, Fetal | HDB | Class 2 | Obstetrics/Gynecology | No | 2003-09-02 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2003-11-19 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2017-05-19 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2012-06-19 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2019-02-05 |
| Breast Pump Kit | OHH | Class 2 | Obstetrics/Gynecology | No | 2013-01-03 |
| Shield, Nipple | HFS | Class 1 | General Hospital | No | 2006-09-21 |
| Nipple, Lambs Feeding | FNN | Class 1 | General Hospital | No | 2006-09-21 |
| Timer, Apgar | LHB | Class 1 | General Hospital | No | 2006-09-21 |
| Utensil, Eating | ILC | Class 1 | Physical Medicine | No | 2013-10-30 |
Proprietary Names
Invia White Foam NPWT - Large
Invia White Foam NPWT - Small
MEDELA BILIBED
PHOTOLAMP PHOTOTHERAPY UNIT
MEDELA PHOTOLAMP PHOTOTHERAPY UNIT
MEDELA THOPAZ
MEDELA BIRD CUP
MEDELA SILC CUP
MEDELA CENTRAL VACUUM REGULATORS
MEDELA THORAX DRAINAGE SYSTEMS
Basic & Dominant Flex, KV-6 Suction Pumps
MEDELA MINI ELECTRIC
Invia Abdominal Dressing Kit
Swing Maxi
Solo
Basic & Dominant Flex, KV-6
MEDELA DOMINANT 50 LIPO, MODEL 600-5706
MEDELA NIPPLE SHIELDS
VARIO 8/18/CI
Invia Liberty NPWT System
MEDELA VARIO 8/18
MEDELA SPECIAL NEEDS FEEDER
MEDELA SOFTFEEDER
MEDELA MINI SPECIAL NEEDS FEEDER
Symphony Reconditioned
Symphony Rental
Symphony Preemie+ Rental
Symphony Plus Rental
Symphony Preemie Consigment Pump
Symphony Plus Breastpump (battery version)
Symphony Breastpump
Symphony Consignment
Symphony Preemie+ Breastpump
Invia Gauze Dressing Kit with FitPad Negative Pressure Wound Dressing Kit
Invia Motion Negative Pressure Wound Therapy System
Invia Liberty Negative Pressure Wound Therapy System
Invia Foam Dressing Kit with FitPad Negative Pressure Wound Therapy System
Invia Integrated Dressing
MEDELA DOMINANT 35 C/I
MEDELA VARIO 8/18/CI
MEDELA BASIC 30
MEDELA DOMINANT 35CI
MEDELA BREAST SHELLS
MEDELA CLASSIC
Magic InBra
MEDELA INVIA LIBERTY
Freestyle
MEDELA BASIC
MEDELA DOMINANT FLEX
MEDELA SYMPHONY
POWERED (MUTIPLE BRANDS)
MEDELA BREASTPUMPS
Invia Motion 30 Days Negative Pressure Wound Therapy system
Invia Motion 120 Days Negative Pressure Wound Therapy system
Invia Motion Endure Negative Pressure Wound Therapy system
Invia Motion 15 Days Negative Pressure Wound Therapy system
Invia Motion 7 Days Negative Pressure Wound Therapy system
Invia Motion 60 Days Negative Pressure Wound Therapy system
lnvia Foam Dressing Kit with FitPad Large 3 pcs
lnvia Foam Dressing Kit with FitPad Small 3 pcs
lnvia Gauze Dressing Kit with FitPad Medium 15 pcs
lnvia FitPad sterile 1 pcs and 10 pcs
lnvia Foam Dressing Kit with FitPad Medium 15 pcs
lnvia Foam Dressing Kit with FitPad Medium 3 pcs
lnvia Foam Dressing Kit with FitPad Small 15 pcs
lnvia Gauze Dressing Kit with FitPad Medium 3 pcs
lnvia Foam Dressing Kit with FitPad Large 15 pcs
lnvia Foam Dressing Kit with FitPad X-Large 3 pcs
lnvia Gauze Dressing Kit with FitPad Large 3 pcs
lnvia Transparent Film - sterile 20 pcs
Freestyle Flex
MEDELA APGAR TIMER
MEDELA LACTINA SELECT
Wound Dressing Set
MEDELA INVIA MOTION
MEDELA DOMINANT 50
MEDELA CLARIO
Medela ® THOPAZ+
CALMITA
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility