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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 16 of 123

Device	Model / Reference	Registries	Class	Status
Artic 6, A3.5 / L 30, CE	66012913	FDA UDI	Class II	Active
Mondial 6i, B1 / L14, CE	66970583	FDA UDI	Class II	Active
Mondial 6i, B2 / L20, CE	66970609	FDA UDI	Class II	Active
Artic 8, BL3 / 10 degree - 30 L, CE	66970447	FDA UDI	Class II	Active
Signum Opaque F	66020078	FDA UDI	Class II	Active
Artic 8, A4 / 30 degree - 32 U, CE	66037021	FDA UDI	Class II	Active
Artic 6, C2 / T 15, CE	66015009	FDA UDI	Class II	Active
Basic 6, A1 / P22, CE	56739209	FDA UDI	Class II	Unknown
Artic digital 6, BL3 / R40D, CE	66983102	FDA UDI	Class II	Active
Basic 6, A2 / L05, CE	56739130	FDA UDI	Class II	Unknown
Basic 6, D2 / L01, CE	56739078	FDA UDI	Class II	Unknown
Basic 6, A3.5 / U02, CE	56739260	FDA UDI	Class II	Unknown
Artic	66080501	FDA UDI	Class II	Active
Premium 6, A1 / R2, CE	66007043	FDA UDI	Class II	Unknown
Artic 8, D3 / 0 degree - 32 U, CE	66015241	FDA UDI	Class II	Active
Mondial 6, C3 / O444, CE	66017162	FDA UDI	Class II	Active
Premium 8, C4 / S, CE	66007263	FDA UDI	Class II	Unknown
Mondial 6, B4 / O525, CE	66017081	FDA UDI	Class II	Active
Mondial 8, BL1 / 35L, CE	66801111	FDA UDI	Class II	Unknown
Artic 8, BL3 / 30 degree - 32 L, CE	66970455	FDA UDI	Class II	Active
Basic 8, B1 / HO, CE	56739534	FDA UDI	Class II	Unknown
Artic 6, D2 / S 35, CE	66015056	FDA UDI	Class II	Active
Mondial 6 DS, A3.5 / O510, CE	66985681	FDA UDI	Class II	Unknown
Artic 6, A4 / L 30, CE	66014091	FDA UDI	Class II	Active
Mondial 6, B2 / T442, CE	66017017	FDA UDI	Class II	Active
VENUS Diamond FLOW SYR 1 x 1, 8G - B2	66040362	FDA UDI	Class II	Active
Mondial 6, BL3 / L369, CE	66801070	FDA UDI	Class II	Active
Mondial 6i DS, A2 / O2, CE	66986248	FDA UDI	Class II	Unknown
Mondial 8i, A3 / 33L, CE	66973803	FDA UDI	Class II	Active
Artic digital 6, B4 / R40D, CE	66983091	FDA UDI	Class II	Active
PALA cre-active, gingiva, pink 3 g	66033463	FDA UDI	Class II	Active
Delara	66071290	FDA UDI	Class II	Active
Mondial 8, A3.5 / 29L, CE	66017322	FDA UDI	Class II	Active
Artic digital 6, D4 / TO40D, CE	66080602	FDA UDI	Class II	Active
Basic 8, A3 / GU, CE	56739515	FDA UDI	Class II	Unknown
Mondial 6i, B4 / O2, CE	66970641	FDA UDI	Class II	Active
Premium 6, D4 / O6, CE	66007042	FDA UDI	Class II	Unknown
Artic 6, BL3 / L 20, CE	66970416	FDA UDI	Class II	Active
Artic 6, D4 / R 40, CE	66015086	FDA UDI	Class II	Active
Signum cre-active	66020058	FDA UDI	Class II	Active
Mondial 6i, A2 / T4, CE	66970485	FDA UDI	Class II	Active
Mondial 6, B2 / O444, CE	66017022	FDA UDI	Class II	Active
Basic 8, B3 / EU, CE	56739584	FDA UDI	Class II	Unknown
Artic digital 6, C1 / L55D, CE	66983120	FDA UDI	Class II	Active
Mondial 6, A1 / S451, CE	66975511	FDA UDI	Class II	Active
Delara	66071173	FDA UDI	Class II	Active
Mondial 8, B3 / 29L, CE	66017362	FDA UDI	Class II	Active
Charisma ABC	66064795	FDA UDI	Class II	Active
Mondial 6i, C2 / L12, CE	66970736	FDA UDI	Class II	Active
Mondial 6i, A2 / S8, CE	66970493	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