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Origio A/S

Last updated May 23, 2026

What Origio A/S makes

Origio A/S produces IVF media, IVF medium kits, assisted reproduction vitrification carriers, and assisted reproduction transfer catheters/sets, including specific products such as BlastGen, Vitrification Kit, Flushing Medium, SAGE 1-Step, SynVitro Flush, ORIGIO Sequential Cleav, VitriGuard, Vitrification Warming Kit, Universal IVF Medium, and others.

The company's devices are classified as Class II and are listed in the FDA 510(k) and FDA UDI registries. Origio A/S is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 305424269

Catalogue (114)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Embryogen	K140317	FDA 510(k)	Class II	Active
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash	K153267	FDA 510(k)	Class II	Active
VitriGuard	K162833	FDA 510(k)	Class II	Active
Sage 1-Step With Human Serum Albumin, Sage 1-Step With Serum Protein Supplements	K133707	FDA 510(k)	Class II	Active
BlastGen	K152932	FDA 510(k)	Class II	Active
ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)	K173624	FDA 510(k)	Class II	Active
Origio Sequential Fert, Origio Sequential Fert With Phenol Red, Origio Sequential Cleav, Origio Sequential Cleav, Origio	K133912	FDA 510(k)	Class II	Active
Transem and EchoGen Embryo Transfer Catheters	K161547	FDA 510(k)	Class II	Active
VitriGuard	K200815	FDA 510(k)	Class II	Active
Medicult Vitrification Cooling/Warming, Model Ref: 1228, 1229	K100367	FDA 510(k)	Class II	Active
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS	K172197	FDA 510(k)	Class II	Active
VitriGuard	K180740	FDA 510(k)	Class II	Active
Origio(r) Sequential Blast Tm; Origio(r) Sequential Blast Tm With Phenol Red	K133387	FDA 510(k)	Class II	Active
Embryogen	K120136	FDA 510(k)	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Origio A/S Ballerup Hovedstaden · DK FEI 3004048494