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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 104 of 123

Device	Model / Reference	Registries	Class	Status
Basic 8, C2 / EO, CE	56739571	FDA UDI	Class II	Unknown
Mondial 6i, A3.5 / S6, CE	66970536	FDA UDI	Class II	Active
Artic 6, BL3 / TO 30, CE	66970413	FDA UDI	Class II	Active
Mondial 6i, B3 / L20, CE	66970631	FDA UDI	Class II	Active
Premium 6, C3 / L22, CE	66006989	FDA UDI	Class II	Unknown
Artic digital 8, A3.5 / 10 degrees-32LD, CE	66080669	FDA UDI	Class II	Active
Artic digital 8, D3 / 10 degrees-32LD, CE	66080779	FDA UDI	Class II	Active
Venus Pearl	66081837	FDA UDI	Class II	Active
Basic 8, A1 / BO, CE	56739401	FDA UDI	Class II	Unknown
Charisma ABC	66064780	FDA UDI	Class II	Active
Mondial 8i, C1 / 33 U, CE	66973874	FDA UDI	Class II	Active
Mondial 6 DS, A3 / L331, CE	66985670	FDA UDI	Class II	Unknown
Mondial 8, C4 / 28L, CE	66802177	FDA UDI	Class II	Active
Artic 6, A3.5 / TO 40, CE	66012892	FDA UDI	Class II	Active
Charisma	66000108	FDA UDI	Class II	Active
Durafill VS	66000027	FDA UDI	Class II	Active
Signum metal bond	66033916	FDA UDI	Class II	Active
Artic	66080363	FDA UDI	Class II	Active
Mondial 6i, C3 / T4, CE	66970749	FDA UDI	Class II	Active
Mondial 6i, D4 / L14, CE	66970847	FDA UDI	Class II	Active
Artic	66080451	FDA UDI	Class II	Active
Artic	66080370	FDA UDI	Class II	Active
Mondial 8, C4 / 37 U, CE	66017419	FDA UDI	Class II	Active
Artic 6, A4 / R 20, CE	66014908	FDA UDI	Class II	Active
Artic 6, A2 / TO 30, CE	66012883	FDA UDI	Class II	Active
Premium 6, C3 / L16, CE	66006940	FDA UDI	Class II	Unknown
Mondial 6i, B1 / T6, CE	66970574	FDA UDI	Class II	Active
Artic 8, B3 / 20 degree - 36 L, CE	66015178	FDA UDI	Class II	Active
Mondial 6, B2 / S502, CE	66975560	FDA UDI	Class II	Active
Premium 8, B2 / L, CE	66007193	FDA UDI	Class II	Unknown
Mondial 6, D3 / L331, CE	66017254	FDA UDI	Class II	Active
Basic 8, C4 / EO, CE	56739573	FDA UDI	Class II	Unknown
Artic 6, D3 / R 20, CE	66015068	FDA UDI	Class II	Active
Artic 6, C4 / L 30, CE	66014096	FDA UDI	Class II	Active
Premium 8, C1 / M, CE	66007228	FDA UDI	Class II	Unknown
Artic 6, D2 / R 20, CE	66015052	FDA UDI	Class II	Active
Delara	66071529	FDA UDI	Class II	Active
Premium 6, B4 / S6, CE	66007131	FDA UDI	Class II	Unknown
Premium 6, B3 / R2, CE	66007050	FDA UDI	Class II	Unknown
Premium 8, C3 / XSL, CE	66007310	FDA UDI	Class II	Unknown
Mondial 6, A3 / L384, CE	66016925	FDA UDI	Class II	Active
PalaXpress ultra, pink live, 1000g	66034259	FDA UDI	Class II	Unknown
Artic 6, A1 / O 20, CE	66012875	FDA UDI	Class II	Active
Mondial 8, B1 / 35 U, CE	66017347	FDA UDI	Class II	Active
Mondial 6i DS, A1 / L12, CE	66986233	FDA UDI	Class II	Unknown
Delara	66071578	FDA UDI	Class II	Active
Premium 6, A3.5 / L16, CE	66006932	FDA UDI	Class II	Unknown
FLEXITIME XTREME2 DYN.HEAVY TRAY 2x380ml	66065537	FDA UDI	Class II	Active
Signum matrix	66019691	FDA UDI	Class II	Active
Artic 8, A4 / 30 degree - 30 U, CE	66037019	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