Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807523

FEI Number

3002807523

Entity Name

MEDELA AG

City/State/Country

BAAR Zug, CH

Establishment Address

LAETTICHSTRASSE 4B, BAAR Zug CH-6340, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDELA AG (Owner Number: 8030974)

Owner / Operator Contact Address

LAETTICHSTRASSE 4b, --, BAAR, CH-NOTA CH-6340, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080357

PMA Number

N/A

All Registered 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 MEDELA THOPAZ Invia Abdominal Dressing Kit Swing Maxi Solo Basic & Dominant Flex, KV-6 Basic & Dominant Flex, KV-6 Suction Pumps MEDELA BIRD CUP MEDELA SILC CUP MEDELA DOMINANT 50 LIPO, MODEL 600-5706 MEDELA PHOTOLAMP PHOTOTHERAPY UNIT MEDELA BILIBED 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-11-13
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2006-09-21
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2013-03-26
HDB	Extractor, Vacuum, Fetal	Obstetrics/Gynecology	Class 2	884.4340	2003-09-02
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2003-11-19
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2017-05-19
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2012-06-19
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2012-06-19
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2019-02-05
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-02-05
OHH	Breast Pump Kit	Obstetrics/Gynecology	Class 2	884.5160	2013-01-03
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2021-09-14
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2015-04-23
HDB	Extractor, Vacuum, Fetal	Obstetrics/Gynecology	Class 2	884.4340	2003-09-02
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2012-06-19
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2006-09-21
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2006-09-21
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2016-06-08
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2015-06-29
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2007-11-27
FNN	Nipple, Lambs Feeding	General Hospital	Class 1	880.5640	2006-09-21
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2015-12-17
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-09-19
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-07-18
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2012-06-19
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2003-07-25
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2013-11-21
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2013-11-21
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-09-19
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2012-05-22

Official Correspondent

No official correspondent registered.

US Agent Details

Tim Karlovsky Business: Medela LLC Email: Tim.Karlovsky@medela.com Phone: (815) 3493708

Related Public Records

Same Entity

MEDELA AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1419937	MEDELA LLC	MCHENRY, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807523. Last updated year: 2026. Please use registration number 3002807523 when referencing this establishment in official correspondence.