Facility

ORIGIO A/S

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)	3004048494
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	Lautrupvang 2, 1st Ballerup Hovedstaden, DK 2750
Registration status	Active · expires 2026
Parent company	ORIGIO A/S (owner-operator 9012179)
Brand names	EmbryoGen® (1204); Kit 1206

Activity by year

Recalls (1)

Devices registered here (1)

Media, Reproductive
Product code MQL (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.6180

Recalls & enforcement

Class IITerminated2014-06-20
Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration

All facilities operated by ORIGIO A/S

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. “ORIGIO A/S (FEI 3004048494) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004048494-origio-a-s/

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