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Kulzer, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 4315 S. Lafayette Blvd., SOUTH BEND, IN, 46614
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1821514
DUNS Number: —

Catalogue (6131)

Page 5 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8i, BL2 / 35 U, CE	66973860	FDA UDI	Class II	Active
Mondial 6, D3 / T435, CE	66975642	FDA UDI	Class II	Active
Mondial 6, A4 / S502, CE	66975544	FDA UDI	Class II	Active
Mondial 6, C4 / S445, CE	66017195	FDA UDI	Class II	Active
Artic digital 6, C2 / TO05D, CE	66080489	FDA UDI	Class II	Active
Mondial 8, A1 / 31 U, CE	66017293	FDA UDI	Class II	Active
Artic 6, B2 / S 35, CE	66014944	FDA UDI	Class II	Active
Artic 6, A3 / S 35, CE	66014880	FDA UDI	Class II	Active
Artic digital 8, D2 / 10 degrees-30 UD, CE	66080766	FDA UDI	Class II	Active
Artic 6, C1 / T 20, CE	66014013	FDA UDI	Class II	Active
Mondial 6, A2 / S453, CE	66016888	FDA UDI	Class II	Active
Artic digital 6, D4 / O10D, CE	66080588	FDA UDI	Class II	Active
Mondial 6 DS, A3.5 / L341, CE	66985707	FDA UDI	Class II	Unknown
Mondial 6, BL2 / R520, CE	66975582	FDA UDI	Class II	Active
Artic 8, D4 / 30 degree - 32 L, CE	66037088	FDA UDI	Class II	Active
Signum composite	66020027	FDA UDI	Class II	Active
Mondial 6, BL3 / S502, CE	66975592	FDA UDI	Class II	Active
Artic digital 8, D4 / 20 degrees-30LD, CE	66080791	FDA UDI	Class II	Active
Mondial 6, C4 / L362, CE	66017200	FDA UDI	Class II	Active
Artic 6, A3 / T 20, CE	66012849	FDA UDI	Class II	Active
Artic	66080319	FDA UDI	Class II	Active
Delara	66071166	FDA UDI	Class II	Active
Artic 6, A2 / L 15, CE	66014871	FDA UDI	Class II	Active
Artic 6, D4 / S 05, CE	66015087	FDA UDI	Class II	Active
Artic digital 6, C3 / L05D, CE	66080515	FDA UDI	Class II	Active
Delara	66071524	FDA UDI	Class II	Active
VENUS Diamond FLOW PLT 20x0, 20g - OM	66040376	FDA UDI	Class II	Active
Delara	66071170	FDA UDI	Class II	Active
Artic	66080340	FDA UDI	Class II	Active
VENUS PEARL PLT REFILL 10x0, 2G OB	66048095	FDA UDI	Class II	Active
Delara	66071458	FDA UDI	Class II	Active
PalaXpress ultra pink live, 12000g	66051801	FDA UDI	Class II	Unknown
Artic	66080564	FDA UDI	Class II	Active
Dima	66075558	FDA UDI	Class II	Unknown
Venus Pearl	66048183	FDA UDI	Class II	Active
Mondial 6 DS, B1 / R483, CE	66985759	FDA UDI	Class II	Unknown
Artic digital 8, A4 / 20 degrees-30LD, CE	66080681	FDA UDI	Class II	Active
Artic	66080743	FDA UDI	Class II	Active
Artic	66080662	FDA UDI	Class II	Active
Venus Pearl	66048181	FDA UDI	Class II	Active
Mondial 6, BL3 / S451, CE	66975591	FDA UDI	Class II	Active
Mondial 8, C1 / 32L, CE	66802163	FDA UDI	Class II	Active
Artic digital 8, D2 / 20 degree-36LD, CE	66983276	FDA UDI	Class II	Active
Artic digital 8, A2 / 20 degree-34 UD, CE	66983195	FDA UDI	Class II	Active
Artic 6, A1 / L 15, CE	66014855	FDA UDI	Class II	Active
Mondial 6 DS, A2 / L331, CE	66985634	FDA UDI	Class II	Unknown
Charisma	66000107	FDA UDI	Class II	Active
Delara	66071454	FDA UDI	Class II	Active
Artic	66080462	FDA UDI	Class II	Active
Delara	66071471	FDA UDI	Class II	Active

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FDA Establishments (2)

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

Kulzer Gmbh HANAU Hesse · DE FEI 3005665377
Kulzer SRL Sacalaz-Judet Timis · RO FEI 3011203516