Facility

OMNIA SRL

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004361903
Establishment type	Manufacture Medical Device
Location	VIA F.DELNEVO 190 FIDENZA Parma, IT 43036
Registration status	Active · expires 2026
Parent company	Omnia SRL (owner-operator 9059817)
Brand names	Omnitex sheath

Activity by year

Recalls (1)

Devices registered here (1)

Chair, Dental, Without Operative Unit
Product code NRU (opens in a new tab) · Class I · Dental · 21 CFR 872.6250

Recalls & enforcement

Class IITerminated2021-03-30
Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “OMNIA SRL (FEI 3004361903) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004361903-omnia-srl/

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