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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 90 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 6, D4 / T35D, CE	66080597	FDA UDI	Class II	Active
Mondial 8, BL1 / 28L, CE	66802201	FDA UDI	Class II	Unknown
Artic 6, C4 / TO 30, CE	66014060	FDA UDI	Class II	Active
Xantasil	66052102	FDA UDI	Class II	Active
Cuttersil Mucosa 1x140 Ml	65767011	FDA UDI	Class II	Active
Mondial 8i, D4 / LL, CE	66970997	FDA UDI	Class II	Active
Basic 6, C1 / A13, CE	56739058	FDA UDI	Class II	Unknown
Mondial 8i, A1 / 31L, CE	66973785	FDA UDI	Class II	Active
Delara	66071498	FDA UDI	Class II	Active
Basic 6, D2 / U01, CE	56739254	FDA UDI	Class II	Unknown
Artic digital 8, A3 / 20 degree-32 UD, CE	66983199	FDA UDI	Class II	Active
Mondial 8i, C2 / 33L, CE	66973883	FDA UDI	Class II	Active
Artic digital 8, C3 / 10 degrees-32LD, CE	66080749	FDA UDI	Class II	Active
Delara	66071677	FDA UDI	Class II	Active
Mondial 6, C4 / T495, CE	66975629	FDA UDI	Class II	Active
Basic 6, A1 / L05, CE	56739129	FDA UDI	Class II	Unknown
Premium 6, C3 / L18, CE	66006956	FDA UDI	Class II	Unknown
Artic 6, B4 / S 05, CE	66014975	FDA UDI	Class II	Active
Basic 8, A2 / GU, CE	56739514	FDA UDI	Class II	Unknown
Basic 8, A1 / CO, CE	56739433	FDA UDI	Class II	Unknown
Mondial 8, A1 / 37 U, CE	66017299	FDA UDI	Class II	Active
Artic 6, C3 / S 20, CE	66013978	FDA UDI	Class II	Active
Artic digital 6, C1 / O20D, CE	66080457	FDA UDI	Class II	Active
Delara	66071466	FDA UDI	Class II	Active
Mondial 6, D2 / O510, CE	66017220	FDA UDI	Class II	Active
Artic 6, B4 / L 25, CE	66014984	FDA UDI	Class II	Active
Artic digital 6, B4 / L05D, CE	66080449	FDA UDI	Class II	Active
Basic 6, B2 / A13, CE	56739055	FDA UDI	Class II	Unknown
Basic 6, C2 / U05, CE	56739315	FDA UDI	Class II	Unknown
Artic 6, C3 / R 30, CE	66015021	FDA UDI	Class II	Active
Signum matrix	66019697	FDA UDI	Class II	Active
Mondial 6 DS, A1 / T450, CE	66985591	FDA UDI	Class II	Unknown
Basic 6, B3 / U05, CE	56739312	FDA UDI	Class II	Unknown
Basic 6, B2 / P23, CE	56739231	FDA UDI	Class II	Unknown
Artic	66080297	FDA UDI	Class II	Active
Mondial 8, C4 / 28 U, CE	66802176	FDA UDI	Class II	Active
Artic digital 8, D4 / 20 degrees-30 UD, CE	66080790	FDA UDI	Class II	Active
Mondial 6, B3 / T440, CE	66975571	FDA UDI	Class II	Active
Artic	66080713	FDA UDI	Class II	Active
Mondial 6, BL3 / L382, CE	66801073	FDA UDI	Class II	Active
Mondial 8, B4 / 37 U, CE	66017379	FDA UDI	Class II	Active
Artic 6, A2 / TO 10, CE	66014868	FDA UDI	Class II	Active
Mondial 6i, D4 / T4, CE	66970837	FDA UDI	Class II	Active
Mondial 6, A3.5 / R410, CE	66016927	FDA UDI	Class II	Active
Delara	66071197	FDA UDI	Class II	Active
Mondial 6i, B1 / O6, CE	66970577	FDA UDI	Class II	Active
Mondial 6i, B2 / O4, CE	66970598	FDA UDI	Class II	Active
Mondial 6, BL3 / R449, CE	66801054	FDA UDI	Class II	Active
Delara	66071653	FDA UDI	Class II	Active
Mondial 6, C2 / T495, CE	66975613	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