MEDELA LLC

Registration Details

Registration Name: MEDELA LLC
Registration Number: 1419937
FEI Number: 1419937
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 1101 CORPORATE DR.
City: MCHENRY
State: IL
ZIP: 60050
Country: US

Regulatory Submissions

510(k) Number: K894206

Owner / Operator

Firm Name: MEDELA AG
Operator Number: 8030974
Address: LAETTICHSTRASSE 4b, --
City: BAAR
State: CH-NOTA
Postal Code: CH-6340
Country: CH

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Syringe, Piston	FMF	Class 2	General Hospital	No	2014-05-22
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	PWA	Class 1	Obstetrics/Gynecology	No	2026-03-10
Enteral Syringes With Enteral Specific Connectors	PNR	Class 2	Gastroenterology, Urology	No	2017-09-19
Pump, Breast, Non-Powered	HGY	Class 1	Obstetrics/Gynecology	No	2007-11-27
Shield, Nipple	HFS	Class 1	General Hospital	No	2006-09-21
Scale, Patient	FRW	Class 1	General Hospital	No	2002-04-02
Breast Pump Kit	OHH	Class 2	Obstetrics/Gynecology	No	2013-01-03
Negative Pressure Wound Therapy Powered Suction Pump	OMP	Class 2	General, Plastic Surgery	No	2013-01-07
Pump, Portable, Aspiration (Manual Or Powered)	BTA	Class 2	General, Plastic Surgery	No	2003-07-25
Nursing Pad, Hydrogel	NTC	Class 1	General Hospital	No	2011-12-09
Pack, Hot Or Cold, Reusable	IME	Class 1	Physical Medicine	No	1991-02-25
Pump, Breast, Powered	HGX	Class 2	Obstetrics/Gynecology	No	2026-04-13
Tubes, Gastrointestinal (And Accessories)	KNT	Class 2	Gastroenterology, Urology	No	2014-05-23
Warmer, Thermal, Infusion Fluid	LGZ	Class 2	General Hospital	No	2014-05-23
Nipple, Lambs Feeding	FNN	Class 1	General Hospital	No	2006-09-21
Set, Administration, Intravascular	FPA	Class 2	General Hospital	No	2014-05-23
Unit, Neonatal Phototherapy	LBI	Class 2	General Hospital	No	2006-09-21
Bottle, Collection, Vacuum	KDQ	Class 2	General Hospital	No	2003-11-19
Adaptor, Holder, Syringe	IQG	Class 1	Physical Medicine	No	2026-03-10

Proprietary Names

Intopo Oral Syringe Adapter Medela Low Dose Enteral Syringe Portable Manual Pump MEDELA NIPPLE SHIELDS Babyweigh II scale Baby Checker Scale Wound Dressing Set MEDELA INVIA MOTION MEDELA VARIO 8/18/CI MEDELA BASIC 30 MEDELA DOMINANT 35CI Tender Care Hydrogel Pad BRA COMPRESS GEL PAD Freestyle Mini Hands-free breast pump Feeding Tube Guardian Warmer Advanced Personal Double Breastpump; Pump In Style Advanced MEDELA CLARIO MEDELA SPECIAL NEEDS FEEDER MEDELA SOFTFEEDER MEDELA MINI SPECIAL NEEDS FEEDER MEDELA VARIO 8/18 Enteral Syringe with ENFit Connector Starter SNS Supplemental Nursing System (SNS) MEDELA SYMPHONY POWERED (MUTIPLE BRANDS) MEDELA BREASTPUMPS Pump In Style Nipple Shield Contact Nipple Shield Swing Maxi Solo 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 Extension Set MEDELA BILIBED PHOTOLAMP PHOTOTHERAPY UNIT MEDELA PHOTOLAMP PHOTOTHERAPY UNIT sonata warranty sonata sonata deluxe Freestyle Flex MEDELA CENTRAL VACUUM REGULATORS MEDELA THORAX DRAINAGE SYSTEMS MEDELA LACTINA SELECT Pump In Style Advanced Advanced Personal Double Breastpump Oral Feeding Syringe Piston Syringe Harmony

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility