Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2025182

FEI Number

2025182

Entity Name

Freudenberg Medical, LLC

City/State/Country

CARPINTERIA, CA, US

Establishment Address

1110 Mark Ave, CARPINTERIA, CA 93013, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Freudenberg Medical, LLC (Owner Number: 2025182)

Owner / Operator Contact Address

Freudenberg Medical, LLC, 1110 Mark Avenue, Carpinteria, CA 93013, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ENW	Catheter, Nasopharyngeal	Ear, Nose, Throat	Class 1	874.4175	2013-12-17
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2019-02-14
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	1998-07-24
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2014-03-28
HQJ	Implant, Absorbable, (Scleral Buckling Methods)	Ophthalmic	Class 2	886.3300	2020-05-29
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-01-29
HHW	Pessary, Vaginal	Obstetrics/Gynecology	Class 2	884.3575	2020-05-28
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	Class 2	874.3730	2009-01-08
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	Class 2	874.3730	2009-01-08
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2014-03-07
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2009-10-08
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	Class 2	874.3730	2009-01-08
LFB	Button, Nasal Septal	Unknown	Class U	N/A	2014-03-28
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2009-10-08
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	Class 2	874.3730	2009-01-08
KAC	Tube, Laryngectomy	Ear, Nose, Throat	Class 1	874.4420	2013-12-17
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2025-02-13
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	Class 2	874.3730	2009-01-08
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	Class 2	874.3730	2009-01-08
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	Class 2	874.3730	2009-01-08
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	Class 2	874.3730	2009-01-08
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2025-03-14
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	Class 2	874.3730	2024-12-26
LTI	Implant, Intragastric For Morbid Obesity	Unknown	Class 3	N/A	2013-12-17

Official Correspondent

Rhonda Kops

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Freudenberg Medical, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012268721	Freudenberg Medical Plastic & Metal Manufacturing (Shenzhen) Co., Ltd.	Shenzhen Guangdong, CN
2031897	Freudenberg Medical, LLC	Baldwin Park, CA, US
1222140	FREUDENBERG MEDICAL, LLC	Jeffersonville, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K933654	Johnson & Johnson Medical, Inc.	BLADDER NECK SUPPORT PROTHESIS FITTING KIT	1995-05-04
K823749	Bivona Medical Technologies	LOW PRESSURE BLOM-SINGER VOICE PROSTHES	1983-01-07
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

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3003915875	MARTECH MEDICAL PRODUCTS S. DE RL. DE CV.	MEXICALI Baja California, MX
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025182. Last updated year: 2026. Please use registration number 2025182 when referencing this establishment in official correspondence.