Facility

DIGNITANA AB

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)	3008888703
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	Traktorgranden 3 Lund Skane, SE 22660
Registration status	Active · expires 2026
Parent company	Dignitana Inc (owner-operator 10050834)
Brand names	DigniCap

Activity by year

Recalls (1)

Devices registered here (1)

Scalp Cooling System
Product code PMC (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4360

Recalls & enforcement

Class IITerminated2021-11-05
Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with in…

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. “DIGNITANA AB (FEI 3008888703) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008888703-dignitana-ab/

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