Facility

TISSIUM SA

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)	3021453307
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	18 Avenue Leon Gaumont Paris 20e Arrondissement, FR 75020
Registration status	Active · expires 2026
Parent company	TISSIUM (owner-operator 10093777)
Brand names	COAPTIUM Connect; TISSIUM LIGHT

Activity by year

Recalls (1)

Devices registered here (1)

In Situ Polymerizing Peripheral Nerve Repair Device
Product code SFD (opens in a new tab) · Class II · Neurology · 21 CFR 882.5270

Recalls & enforcement

Class IIOngoing2026-06-15
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device …

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. “TISSIUM SA (FEI 3021453307) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021453307-tissium-sa/

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