Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004361903

FEI Number

3004361903

Entity Name

OMNIA SRL

City/State/Country

FIDENZA Parma, IT

Establishment Address

VIA F.DELNEVO 190, FIDENZA Parma 43036, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Omnia SRL (Owner Number: 9059817)

Owner / Operator Contact Address

1666 E Touhy Ave, Des Plaines, IL 60018, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Omnia Kidney Tray Omnia procedure mask Suture Omnia in PTFE RAY BARRIER LIGHT BARRIER OMNITEX C SENSOTEX OMNITEX U PTFE sutures Hu-Friedy STERILE AND NON STERILE GAUZES MAXIL SURGICAL PROCEDURE PACKS Omnia surgical accessories STERILE PROTECTION FILM Omnia Surgical line OMNICAPS Omnitex sheath SplitAir Omnia Surgical Drape IRRIGATION LINE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-03-31
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-03-31
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2014-02-18
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2011-04-01
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2018-04-20
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2013-01-21
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2012-05-21
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-06-29
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2011-06-29
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2011-06-29
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-06-29
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2015-03-31
FXT	Film, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2012-07-18
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2015-01-14
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2013-01-21
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2013-01-21
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2015-03-31
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2003-11-24
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-03-31
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2003-11-24

Official Correspondent

No official correspondent registered.

US Agent Details

Stephanie Wasielewski Business: Hu-Friedy Mfg Co LLC Email: swasielewski@hu-friedy.com Phone: (847) 2574500

Related Public Records

Same Entity

Omnia SRL

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011710821	OMNIA SRL	Mirandola Modena, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004361903. Last updated year: 2026. Please use registration number 3004361903 when referencing this establishment in official correspondence.