Facility

NOVUS SCIENTIFIC AB

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

Key facts

1recalls · worst Class II

2inspections · worst NAI

—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)	3010187263
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	Virdings Alle 2 Uppsala, SE 75450
Registration status	Active · expires 2026
Parent company	Novus Scientific AB (owner-operator 10034484)
Brand names	TIGR Matrix Surgical Mesh

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (3)

Mesh, Surgical, Polymeric
Product code FTL (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3300
Surgical Film
Product code OOD (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3300
Mesh, Surgical, Absorbable, Abdominal Hernia
Product code OWT (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3300

Recalls & enforcement

Class IITerminated2016-07-19
Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.

FDA inspections (2)

NAI2025-01-23
No Action Indicated · Compliance: Devices
NAI2017-10-24
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Novus Scientific AB

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. “NOVUS SCIENTIFIC AB (FEI 3010187263) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010187263-novus-scientific-ab/

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