Omnia S R L

FDA Filings

This page includes the latest FDA filings for Omnia S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004361903
FEI Number3004361903
NameOMNIA SRL
Owner & OperatorOMNIA SRL
Contact AddressVIA F.DELNEVO 190 SX --
FIDENZA IT-PR Parma 43036 IT
Official Correspondent
  • ALEXANDER - KEIM
  • 039-0524-527453-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressVIA F.DELNEVO 190
FIDENZA Parma, 43036 IT
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3010097603
FEI Number3010097603
NameOmnia LLC
Owner & OperatorOMNIA SRL
Contact AddressVIA F.DELNEVO 190 SX --
FIDENZA IT-PR Parma 43036 IT
Official Correspondent
  • ALEXANDER - KEIM
  • 039-0524-527453-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address301 Pleasant St
Abbottstown, PA 17301 US



FDA Filings

Device
Company
DeviceDate
OMNIA SRL
Irrigation line, Kavo 2023-08-16
OMNIA SRL
Irrigation line, Kavo 2023-08-16
OMNIA SRL
Tubing cover sleeve 2023-07-06
OMNIA SRL
Disposable Handle light Covers 2023-07-06
OMNIA SRL
Barrier sleeves for Osstell Beacon ISQ device - sterile 2023-07-06
OMNIA SRL
Omnisleeve 2023-07-06
OMNIA SRL
Omnisleeve 2023-07-06
OMNIA SRL
Medical grade adhesive tapes 10x5 cm for fixing sheaths and drapes 2023-07-06
OMNIA SRL
Sheaths 240x7 cm with adhesive fixing tapes 2023-07-06
OMNIA SRL
Sheaths 120x7 cm with adhesive fixing tapes 2023-07-06
OMNIA SRL
Sheaths 240x7 cm cm with fixing elastics 2023-07-06
OMNIA SRL
Sheaths 120x7 cm with fixing elastics 2023-07-06
OMNIA SRL
Transparent drape 40x50 cm with adhesive tape for physiodispensers or for contro 2023-07-06
OMNIA SRL
Universal seat cover and backrest cover Shell Cover 2023-07-06
OMNIA SRL
Omnicover 2023-07-06
OMNIA SRL
Transparent bag 67x75 cm with sliding ties for physiodispensers or for control u 2023-07-06
OMNIA SRL
Surgical suction tube 1.85 m with conical fitting 2023-07-03
OMNIA SRL
Sterile Aspiration Tips 2023-07-03
OMNIA SRL
Sterile Aspiration Tips 2023-07-03
OMNIA SRL
Surgical aspirator 2.20 m with cannula Yankauer without aspiration control 2023-07-03
OMNIA SRL
Suction set 2.20 m with terminal cannula Omniasp and autologous bone filterl 2023-07-03
OMNIA SRL
Surgical aspirator 2.20 m with Yankauer suction tip, with aspiration control 2023-07-03
OMNIA SRL
Special Plus model gown (length 145 cm) size XXL 2023-06-30
OMNIA SRL
Special Plus model gown (length 118 cm) size XL 2023-06-30
OMNIA SRL
Special Plus model gown (length 115 cm) size L 2023-06-30
OMNIA SRL
Special Plus model gown (length 109 cm ) size S 2023-06-30
OMNIA SRL
Light blue gown with elastics (length 120 cm) 2023-06-30
OMNIA SRL
Yellow gown with cuffs (length 120 cm) 2023-06-30
OMNIA SRL
Yellow gown with elastics (length 120 cm) 2023-06-30
OMNIA SRL
Light blue gown with cuffs (length 120 cm) 2023-06-30
OMNIA SRL
Expo model gown (length 135 cm) size XXL 2023-06-30
OMNIA SRL
Expo model gown (length 133 cm) size XL 2023-06-30
OMNIA SRL
Expo model gown (length 130 cm) size M/L 2023-06-30
OMNIA SRL
Green gown with cuffs (length 120 cm) 2023-06-30
OMNIA SRL
Green gown with elastics (length 120 cm) 2023-06-30
OMNIA SRL
Special Plus model gown (length 130 cm) size XXL 2023-06-30
OMNIA SRL
Special Plus model gown (length 118 cm) size XL 2023-06-30
OMNIA SRL
Special Plus model gown (length 112 cm) size L 2023-06-30
OMNIA SRL
Special Plus model gown (length 112 cm) size M 2023-06-30
OMNIA SRL
Special Plus model gown (length 112 cm) size S 2023-06-30
OMNIA SRL
Light blue gown with elastics (length 120 cm) 2023-06-30
OMNIA SRL
Yellow gown with cuffs (length 120 cm) 2023-06-30
OMNIA SRL
Yellow gown with elastics (length 120 cm) 2023-06-30
OMNIA SRL
Light blue gown with cuffs (length 120 cm) 2023-06-30
OMNIA SRL
Expo model gown (length 118 cm) size S 2023-06-30
OMNIA SRL
Expo model gown (length 133 cm) size XL 2023-06-30
OMNIA SRL
Expo model gown (length 130 cm) size M/L 2023-06-30
OMNIA SRL
Green gown with cuffs (length 120 cm) 2023-06-30
OMNIA SRL
Green gown with elastics (length 120 cm) 2023-06-30
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnicap 2023-06-28
OMNIA SRL
Omnitex C 2023-06-28
OMNIA SRL
Omnitex U 2023-06-28
OMNIA SRL
Irrigation line, W&H 2022-02-28
OMNIA SRL
Irrigation line, W&H 2022-02-28
OMNIA SRL
Infusion Sets, Bien Air 2021-10-14
OMNIA SRL
Infusion Sets, Bien Air 2021-10-14
OMNIA SRL
Irrigation line, Bien Air 2021-08-17
OMNIA SRL
Punches, NOBEL 2021-08-17
OMNIA SRL
Punches, NOBEL 2021-08-17
OMNIA SRL
Punches, NOBEL 2021-08-17
OMNIA SRL
Punches, NOBEL 2021-08-17
OMNIA SRL
Punches, NOBEL 2021-08-17
OMNIA SRL
Punches, NOBEL 2021-08-17
OMNIA SRL
Infusion Sets, Bien Air 2021-08-17
OMNIA SRL
Infusion Sets, Bien Air 2021-08-17
OMNIA SRL
Manual irrigation line, Nobel 2021-07-29
OMNIA SRL
Irrigation line, Nobel 2021-07-29
OMNIA SRL
Adhesive film 2021-02-26
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
Sterile PTFE Surgical Suture 2021-02-15
OMNIA SRL
SURGICAL STERILE DRAPE 2021-02-05
OMNIA SRL
SURGICAL STERILE DRAPE 2021-02-05
OMNIA SRL
SURGICAL STERILE DRAPE 2021-02-05
OMNIA SRL
SURGICAL STERILE DRAPE 2021-02-05
OMNIA SRL
SURGICAL STERILE DRAPE 2021-02-05
OMNIA SRL
SURGICAL STERILE DRAPE 2021-02-05
OMNIA SRL
SURGICAL STERILE DRAPE 2021-02-05
OMNIA SRL
SURGICAL STERILE DRAPE 2021-02-05
OMNIA SRL
PTFE sutures2018-04-20
OMNIA SRL
PTFE sutures2018-04-20
OMNIA SRL
Omnia procedure mask2015-03-31
OMNIA SRL
Omnia Isolation Gowns2015-03-31
OMNIA SRL
Omnitex sheath2015-03-31
OMNIA SRL
Omnia surgical accessories2015-03-31
OMNIA SRL
Omnia Surgical Drape2015-03-31
OMNIA SRL
Omnia Medical Adhesives2015-03-31
OMNIA SRL
Omnia accessories2015-03-31
OMNIA SRL
Omnia Kidney Tray2015-03-31
OMNIA SRL
maxil tray for instruments2015-03-31
OMNIA SRL
Omnia Surgical line2015-01-14
OMNIA SRL
Suture Omnia in PTFE2014-02-18
OMNIA SRL
SHOES COVERS2013-01-22
OMNIA SRL
NON STERILE OPERATOR PROTECTION2013-01-22
OMNIA SRL
STERILE AND NON STERILE GAUZES2013-01-21
OMNIA SRL
OMNICAPS2013-01-21
OMNIA SRL
STERILE PROTECTION FILM2012-07-18
OMNIA SRL
MAXIL2012-05-21
OMNIA SRL
SURGICAL PROCEDURE PACKS2011-06-29
OMNIA SRL
SURGICAL PROCEDURE PACKS2011-06-29
OMNIA SRL
SURGICAL PROCEDURE PACKS2011-06-29
OMNIA SRL
SURGICAL PROCEDURE PACKS2011-06-29
OMNIA SRL
SENSOTEX2011-04-01
OMNIA SRL
RAY BARRIER2011-04-01
OMNIA SRL
OMNITEX U2011-04-01
OMNIA SRL
OMNITEX C2011-04-01
OMNIA SRL
LIGHT BARRIER2011-04-01
OMNIA SRL
TISSUE PUNCH2008-06-25
OMNIA SRL
Tubing set disposable, Disposable tube2008-05-09
OMNIA SRL
IRRIGATION LINE2003-11-24
OMNIA SRL
ASPIRATION SYSTEM2003-11-24
OMNIA SRL
SplitAir2003-11-24

Related Finance Registrations
NCAGE CodeAK558OMNIA SRL
NCAGE CodeAH319OMNIA SRL
CAGE CodeAK558OMNIA SRL
CAGE CodeAH319OMNIA SRL
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092531542Livorno,Italy -> Baltimore, MarylandMEDICAL DEVICES HS CODES: 30059050, 30061010, 39269097, 62101010, 62101092, 90184990, 9402 90002029 PKG
2020092529397Livorno,Italy -> Baltimore, MarylandMACHINE PARTS FOR AUTOMATIVE EQUIPMENT2029 CTN
202008211761Livorno,Italy -> Baltimore, MarylandMACHINE PARTS FOR AUTOMATIVE EQUIPMENT3182 CTN
2020080662471Livorno,Italy -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES3 PCS
2020073113300Livorno,Italy -> Baltimore, MarylandMACHINE PARTS FOR AUTOMATIVE EQUIPMENT3182 CTN
2020072223693Livorno,Italy -> Baltimore, MarylandMACHINE PARTS FOR AUTOMATIVE EQUIPMENT3182 CTN
2020071829404Livorno,Italy -> Baltimore, MarylandMACHINE PARTS FOR AUTOMATIVE EQUIPMENT3182 CTN
2020071735117Livorno,Italy -> Baltimore, MarylandMEDICAL DEVICES HS CODE: 30059050 + 30061010 + 39269097 + 44152090 + 63079092 + 63079098 + 90184990 + 90189084 FREIGHT PREPAID3182 PKG

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