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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: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1821514
DUNS Number: —

Catalogue (6131)

Page 11 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6 DS, A3.5 / T435, CE	66985696	FDA UDI	Class II	Unknown
Mondial 6i DS, A3.5 / L12, CE	66986299	FDA UDI	Class II	Unknown
Artic	66080606	FDA UDI	Class II	Active
Mondial 8i DS, A2 / 33 U, CE	66986819	FDA UDI	Class II	Unknown
Artic 8, B4 / 20 degree - 36 L, CE	66015188	FDA UDI	Class II	Active
Artic 6, C4 / S 10, CE	66013970	FDA UDI	Class II	Active
Artic 8, B4 / 20 degree - 30 U, CE	66014120	FDA UDI	Class II	Active
Mondial 6 DS, B1 / L378, CE	66985783	FDA UDI	Class II	Unknown
Delara	66071342	FDA UDI	Class II	Active
Mondial 8, B3 / 33 U, CE	66017365	FDA UDI	Class II	Active
Artic digital 6, C4 / T30D, CE	66983149	FDA UDI	Class II	Active
Mondial 6i, BL2 / L20, CE	66970675	FDA UDI	Class II	Active
Delara	66071551	FDA UDI	Class II	Active
Charisma ABC	66064776	FDA UDI	Class II	Active
Venus Bulk Fill Syringe Intro Kit A3+TE	66046794	FDA UDI	Class II	Unknown
Mondial 6, C3 / T405, CE	66017156	FDA UDI	Class II	Active
Premium 8, B3 / SL, CE	66007274	FDA UDI	Class II	Unknown
Mondial 6i, C4 / T2, CE	66970770	FDA UDI	Class II	Active
Delara	66071440	FDA UDI	Class II	Active
Palapress Vario	64707889	FDA UDI	Class II	Active
Artic digital 6, BL3 / L55D, CE	66983109	FDA UDI	Class II	Active
Mondial living Mould Chart B1	40005504	FDA UDI	Class II	Active
Mondial 6i, A4 / O4, CE	66970554	FDA UDI	Class II	Active
Artic 6, B1 / S 20, CE	66012823	FDA UDI	Class II	Active
Artic 8, A3.5 / 20 degree - 30 L, CE	66012941	FDA UDI	Class II	Active
Mondial 6i, B3 / S8, CE	66970625	FDA UDI	Class II	Active
Basic 6, A3 / L06, CE	56739147	FDA UDI	Class II	Unknown
Basic 6, A4 / U01, CE	56739245	FDA UDI	Class II	Unknown
Delara	66071378	FDA UDI	Class II	Active
Mondial 6, A1 / L373, CE	66016865	FDA UDI	Class II	Active
Premium 6, B1 / L22, CE	66006983	FDA UDI	Class II	Unknown
VENUS DIAMOND PLT REFILL 1x10x0, 25G OXDC	66046734	FDA UDI	Class II	Active
Artic	66080548	FDA UDI	Class II	Active
Venus Diamond Syr Basic Kit + Ibte	66055475	FDA UDI	Class II	Unknown
Basic 8, C2 / FO, CE	56739603	FDA UDI	Class II	Unknown
Basic 8, B3 / EO, CE	56739568	FDA UDI	Class II	Unknown
Mondial 6, B1 / O444, CE	66016994	FDA UDI	Class II	Active
Mondial 6, D3 / T440, CE	66975643	FDA UDI	Class II	Active
Mondial 6, A4 / T495, CE	66975549	FDA UDI	Class II	Active
Artic 6, B4 / S 35, CE	66014976	FDA UDI	Class II	Active
Artic digital 6, B4 / S30D, CE	66983092	FDA UDI	Class II	Active
Artic digital 6, D3 / L20D, CE	66983173	FDA UDI	Class II	Active
Mondial 6i, C4 / L12, CE	66970780	FDA UDI	Class II	Active
Mondial 8 DS, A1 / 35L, CE	66986622	FDA UDI	Class II	Unknown
Mondial 6i, A2 / T6, CE	66970486	FDA UDI	Class II	Active
Mondial 6i, BL2 / O6, CE	66970665	FDA UDI	Class II	Active
Delara	66071315	FDA UDI	Class II	Active
Artic 8, C1 / 30 degree - 32 L, CE	66037052	FDA UDI	Class II	Active
Mondial 8, B2 / 28L, CE	66802141	FDA UDI	Class II	Active
Mondial 6 DS, A1 / L362, CE	66985600	FDA UDI	Class II	Unknown

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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