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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 114 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6i, B2 / R8, CE	66970593	FDA UDI	Class II	Active
Artic 6, A2 / T 30, CE	66012855	FDA UDI	Class II	Active
Artic 6, A3 / S 30, CE	66012828	FDA UDI	Class II	Active
Artic 6, B1 / TO 05, CE	66014931	FDA UDI	Class II	Active
Mondial 6, D2 / R449, CE	66017209	FDA UDI	Class II	Active
Mondial 6, C2 / T405, CE	66017128	FDA UDI	Class II	Active
Mondial 6, B4 / L378, CE	66017091	FDA UDI	Class II	Active
Mondial 8, D3 / 29L, CE	66017432	FDA UDI	Class II	Active
Delara	66071156	FDA UDI	Class II	Active
Artic 8, C2 / 30 degree - 30 U, CE	66037055	FDA UDI	Class II	Active
Delara	66071335	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 2x10x0, 25G B2	66039016	FDA UDI	Class II	Active
Mondial 6i, D2 / L19, CE	66970806	FDA UDI	Class II	Active
Artic digital 8, C4 / 10 degrees-30LD, CE	66080757	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G ODC	66046737	FDA UDI	Class II	Active
Basic 8, A3 / BU, CE	56739419	FDA UDI	Class II	Unknown
Artic 6, B4 / T 10, CE	66014003	FDA UDI	Class II	Active
Mondial 8i, D4 / ML, CE	66970995	FDA UDI	Class II	Active
Premium 6, B3 / T4, CE	66007162	FDA UDI	Class II	Unknown
Mondial 6, D2 / S445, CE	66017223	FDA UDI	Class II	Active
Basic 8, B1 / DO, CE	56739470	FDA UDI	Class II	Unknown
Mondial 6, A1 / T435, CE	66975514	FDA UDI	Class II	Active
Mondial 8, C2 / 33 U, CE	66017395	FDA UDI	Class II	Active
Mondial 6, B2 / O510, CE	66017024	FDA UDI	Class II	Active
Artic 8, D3 / 0 degree - 32 L, CE	66015242	FDA UDI	Class II	Active
Artic 6, D3 / L 25, CE	66015080	FDA UDI	Class II	Active
Mondial 6, C1 / L398, CE	66017122	FDA UDI	Class II	Active
Artic 8, D4 / 20 degree - 34 U, CE	66014162	FDA UDI	Class II	Active
Artic 8, D2 / 0 degree - 32 L, CE	66015232	FDA UDI	Class II	Active
Artic	66080609	FDA UDI	Class II	Active
Artic	66080528	FDA UDI	Class II	Active
Artic	66080545	FDA UDI	Class II	Active
Artic	66080643	FDA UDI	Class II	Active
Delara	66071200	FDA UDI	Class II	Active
Mondial 6 DS, B1 / L331, CE	66985778	FDA UDI	Class II	Unknown
Mondial 8, A3.5 / 32L, CE	66802127	FDA UDI	Class II	Active
Artic digital 8, C2 / 20 degrees-30LD, CE	66080741	FDA UDI	Class II	Active
Flexitime Light Flow 1 X (2 X 50 Ml)	60041061	FDA UDI	Class II	Active
Mondial 6, B4 / O444, CE	66017078	FDA UDI	Class II	Active
Dima	66077059	FDA UDI	Class II	Active
Mondial 6, D2 / R520, CE	66975630	FDA UDI	Class II	Active
Mondial 8, B2 / 33 U, CE	66017355	FDA UDI	Class II	Active
Artic 8, C1 / 0 degree - 30 U, CE	66015189	FDA UDI	Class II	Active
Premium 8, A2 / SL, CE	66007268	FDA UDI	Class II	Unknown
Artic	66080519	FDA UDI	Class II	Active
Artic 6, C1 / R 40, CE	66014990	FDA UDI	Class II	Active
Mondial 8, A1 / 33 U, CE	66017295	FDA UDI	Class II	Active
Premium 6, D3 / L14, CE	66006927	FDA UDI	Class II	Unknown
Delara	66071177	FDA UDI	Class II	Active
Delara	66071481	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