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KOELIS

France·FR-MF-000000830

Last updated September 17, 2026

Information

Country: France
Address: 22, Chemin du vieux chêne, MEYLAN, France
Website: koelis.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +33458176811
PRRC Contact: Laurence WARIN-SIMON
EUDAMED SRN: FR-MF-000000830
FDA FEI Number: 3008487708
DUNS Number: 290318455

Catalogue (42)

Device	Model / Reference	Registries	Class	Status
Steady Pro support for Full-3D endocavity side-fire probe	KPHA.EL.2	EUDAMED	Class I	Active
Steady Pro support for Full-3D endocavity end-fire probe	KPHA.EC.2	EUDAMED	Class I	Active
Steady Pro for Full-3D endocavity side-fire probe	KPHA.01.EL	EUDAMED	Class I	Active
Con Lead 18g	KRNG.AB.18	FDA UDI	Class II	Active
Steady Pro	KPHA.OO.EC	EUDAMEDFDA UDI	Class II	Active
Lin Lead 14g	KRNG.LN.14	FDA UDI	Class II	Active
Mr Draw	KURO-4000	FDA UDI	Class II	Unknown
Steady Pro	KSP.SUPP.TP2	EUDAMEDFDA UDI	Class II	Active
transP - Reusable Guid Perine Nail 18G	KRNG.EL2.18	FDA UDI	Class II	Active
Con Lead 14g	KRNG.AB.14	FDA UDI	Class II	Active
Steady Pro	KSP.UNIVCLAMP	EUDAMEDFDA UDI	Class II	Active
3D Side Fire Endocavity Probe	K3DEL00-2	EUDAMEDFDA UDI	Class II	Active
3D End-Fire Endocavity Probe	K3DEC00-2	EUDAMEDFDA UDI	Class II	Active
NAIL range	NAIL.18	EUDAMEDFDA UDI	Class II	Active
Reusable guide	GPK-490	FDA UDI	Class II	Active
2D Linear Probe	K2DLN00	EUDAMEDFDA UDI	Class II	Active
Trinity	KURO3000-2	FDA UDI	Class II	Unknown
MrDraw	KURO-4000	FDA UDI	Class II	Active
Reusable guide	GPK-490	FDA UDI	Class II	Active
2D Abdominal Probe	K2DAB00	EUDAMEDFDA UDI	Class II	Active
Lin Lead 18g	KRNG.LN.18	FDA UDI	Class II	Active
3D Side-Fire Endocavity Probe	K3DEL00	EUDAMEDFDA UDI	Class II	Active
transP - Reusable Guid Perine Nail 14G	KRNG.EL2.14	FDA UDI	Class II	Active
Perine Full Grid 18G	KRNG.EL4.18	EUDAMEDFDA UDI	Class I	Active
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range	K171040	FDA 510(k)	Class II	Active
3d Prostate Suite 3dtrus Prostate Mapping, Mri/3dtrus Fusion Option, Second Look 3dtrus Fusion Option	K131448	FDA 510(k)	Class II	Active
Urostation 3d Prostate Suite	K100793	FDA 510(k)	Class II	Active
Reusable guide	GPK-490	EUDAMED	Class I	Active
Perine Grid 14g	KRNG.EL1.14	EUDAMEDFDA UDI	Class I	Active
Con Lead	KRNG.AB.1x	EUDAMED	Class I	Active
Trinity	KURO-3000-3	EUDAMEDFDA 510(k)FDA UDI	Class IIa	Active
Steady Pro	KSP.SUPP.TP	EUDAMEDFDA UDI	Class I	Active
Perine Grid 18G	KRNG.EL1.18	EUDAMEDFDA UDI	Class I	Active
Promap Lite	KSOF-2602-Li	EUDAMEDFDA UDI	Class I	Active
Perine Nail	KRNG.EL2.1x	EUDAMED	Class I	Active
Steady Pro	KSP.SUPP.TR	EUDAMEDFDA UDI	Class I	Active
Z-Lock	KRZL.EX	EUDAMED	Class I	Active
Perine Full Grid 14G	KRNG.EL4.14	EUDAMEDFDA UDI	Class I	Active
Nail 14g	NAIL.14	EUDAMEDFDA UDI	Class I	Active
Sterile disposable guide	KDNG00	EUDAMEDFDA UDI	Class I	Active
Steady Pro	KSP.ARM	EUDAMEDFDA UDI	Class I	Active
Perine Adapter	KRGA.EL5	EUDAMEDFDA UDI	Class I	Active

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