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
Phone
815 3493708

Products

Device Name Product Code
Negative Pressure Wound Therapy Powered Suction Pump OMP
Unit, Neonatal Phototherapy LBI
Pump, Portable, Aspiration (Manual Or Powered) BTA
Extractor, Vacuum, Fetal HDB
Bottle, Collection, Vacuum KDQ
System, Suction, Lipoplasty For Removal QPB
Pump, Breast, Powered HGX
Mesh, Surgical, Polymeric FTL
Breast Pump Kit OHH
Shield, Nipple HFS
Nipple, Lambs Feeding FNN
Timer, Apgar LHB
Utensil, Eating ILC

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