Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019543072

FEI Number

3019543072

Entity Name

HYDROFERA, LLC.

City/State/Country

Manchester, CT, US

Establishment Address

8 Progress Drive, --, Manchester, CT 06042, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

HYDROFERA, LLC. (Owner Number: 9028346)

Owner / Operator Contact Address

340 Progress Drive, --, Manchester, CT 06042, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hydrofera Blue Classic Hydrofera Blue Ready - Border Hydrofera Instrument WIpe Keel Sponge Hydrofera Blue Transfer Hydrofera Blue READY Antibacterial Foam Dressing Hydrofera Blue Ready Transfer Hydrofera Femoral Wick BACTERIOSTATIC NASAL Hydrofera Instrument WIpe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-11-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-12-11
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2011-12-09
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2018-06-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-05-11
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2008-01-28
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	1998-03-24
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-12-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HYDROFERA, 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
1225532	HYDROFERA, LLC.	Manchester, CT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K861444	Surgical Specialties, Inc.	S1 NASAL PACKING	1986-05-06
K863737	Hermitage Hospital Products, Inc.	SPONGES STERILE TWIN PAKT AND SINGLES	1986-10-14
K940351	Certified Safety Mfg., Inc.	EXTRA LARGE COMPRESS DRESSING	1994-02-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019543072. Last updated year: 2026. Please use registration number 3019543072 when referencing this establishment in official correspondence.