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IBL INTERNATIONAL GMBH

Germany·DE-MF-000015709

Last updated September 17, 2026

Information

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Melatonin-Sulfate Urine ELISA	RE54031	EUDAMED	Class B	Active
17beta-Estradiol Saliva Luminescence Immunoassay	RE62141	EUDAMEDFDA UDI	Class B	Active
Cortisol Saliva Luminescence Immunoassay	K150528	FDA 510(k)	Class II	Active
DHEA Saliva ELISA	RE52651	EUDAMED	Class B	Active
17beta-Estradiol Saliva ELISA	30121045	EUDAMEDFDA UDI	Class B	Active
Neopterin ELISA	RE59321	EUDAMED	Class B	Active
Acetylcholine Receptor Autoantibodies (ARAb) RRA	30221149	EUDAMED	Class B	Active
Free Testosterone ELISA	DB52181	EUDAMED	Class B	Active
Acetylcholine Receptor Autoantibodies (ARAb) RRA	KIPIB21021	EUDAMED	Class B	Active
MuSK-Ab ELISA	RE51021	EUDAMED	Class B	Active
Estriol high sensitive Saliva ELISA	30121046	EUDAMED	Class B	Active
SaliCap Set	RE69985	EUDAMED	Class A	Active
17beta-Estradiol Saliva Luminescence Immunoassay	RE62149	EUDAMEDFDA UDI	Class B	Active
Melatonin direct Saliva ELISA	RE54041	EUDAMED	Class B	Active
Testosterone Saliva ELISA	RE52631	EUDAMED	Class B	Active
25-OH-Vitamin D ELISA	RE53041	EUDAMED	Class B	Active
Testosterone Saliva Luminescence Immunoassay	30191569	EUDAMED	Class B	Active
Progesterone Saliva ELISA	RE52281	EUDAMED	Class B	Active
Acetylcholine Receptor Autoantibodies (ARAb) RRA	30221148	EUDAMED	Class B	Active
17-OH-Progesterone ELISA	RE52071	EUDAMED	Class B	Active
Histamine ELISA	RE59221	EUDAMED	Class B	Active
Phenylalanine (PKU) neonatal Screening Assay	RE80019	EUDAMED	IVD Annex II List B	Active
dsDNA-Ab RIA	KIPIB19011	EUDAMED	Class B	Active
sInterleukin-2-Receptor ELISA	30201813	EUDAMED	Class B	Active

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