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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 117 of 123

Device	Model / Reference	Registries	Class	Status
Artic 8, C3 / 30 degree - 34 U, CE	66037065	FDA UDI	Class II	Active
Mondial 6i, A2 / L20, CE	66970499	FDA UDI	Class II	Active
Basic 8, A3.5 / DO, CE	56739468	FDA UDI	Class II	Unknown
Artic	66080452	FDA UDI	Class II	Active
Artic digital 6, A1 / T20D, CE	66080266	FDA UDI	Class II	Active
Delara	66071518	FDA UDI	Class II	Active
Artic 8, B1 / 0 degree - 30 U, CE	66015149	FDA UDI	Class II	Active
Mondial 8i, A3 / LL, CE	66970877	FDA UDI	Class II	Active
Artic digital 6, C3 / O10D, CE	66080500	FDA UDI	Class II	Active
Basic 8, A1 / CU, CE	56739449	FDA UDI	Class II	Unknown
Premium 6, C4 / R6, CE	66007087	FDA UDI	Class II	Unknown
Artic 8, BL3 / 20 degree - 36 L, CE	66970451	FDA UDI	Class II	Active
Mondial 8, A3.5 / 31 U, CE	66017323	FDA UDI	Class II	Active
Artic 6, A4 / R 40, CE	66014910	FDA UDI	Class II	Active
Mondial 6, B3 / L382, CE	66017064	FDA UDI	Class II	Active
Artic 8, A3 / 20 degree - 30 U, CE	66012933	FDA UDI	Class II	Active
Mondial 6i, D3 / S8, CE	66970823	FDA UDI	Class II	Active
Artic digital 6, A3.5 / TO20D, CE	66983040	FDA UDI	Class II	Active
HeraCeram Pastenopaker PO C2, 2ml	66003354	FDA UDI	Class II	Unknown
Artic 6, C2 / L 55, CE	66015018	FDA UDI	Class II	Active
Artic digital 8, B3 / 20 degree-32LD, CE	66983230	FDA UDI	Class II	Active
Artic 6, BL3 / O 10, CE	66970411	FDA UDI	Class II	Active
Basic 6, D3 / P22, CE	56739223	FDA UDI	Class II	Unknown
Mondial 6, B2 / R420, CE	66017012	FDA UDI	Class II	Active
Artic digital 8, A1 / 10 degrees-30 UD, CE	66080636	FDA UDI	Class II	Active
Delara	66071483	FDA UDI	Class II	Active
Artic 6, B3 / R 40, CE	66014958	FDA UDI	Class II	Active
Premium 6, C2 / L16, CE	66006939	FDA UDI	Class II	Unknown
Artic digital 6, D4 / R40D, CE	66983179	FDA UDI	Class II	Active
Mondial 8, D3 / 30 U, CE	66802190	FDA UDI	Class II	Active
Artic digital 8, D3 / 20 degree-32 UD, CE	66983277	FDA UDI	Class II	Active
Mondial 6, A3 / S502, CE	66975528	FDA UDI	Class II	Active
Premium 6, B2 / R2, CE	66007049	FDA UDI	Class II	Unknown
Mondial 8i, A3 / 33 U, CE	66973802	FDA UDI	Class II	Active
Delara	66071451	FDA UDI	Class II	Active
Delara	66071613	FDA UDI	Class II	Active
Delara	66071370	FDA UDI	Class II	Active
Basic 8, A4 / DO, CE	56739469	FDA UDI	Class II	Unknown
Mondial 6i, A4 / L20, CE	66970565	FDA UDI	Class II	Active
Venus	66079659	FDA UDI	Class I	Active
Premium 6, D4 / T6, CE	66007186	FDA UDI	Class II	Unknown
Mondial 8, B1 / 33 U, CE	66017345	FDA UDI	Class II	Active
Artic 8, C1 / 10 degree - 32 U, CE	66015195	FDA UDI	Class II	Active
Delara	66071163	FDA UDI	Class II	Active
Artic 8, A3.5 / 30 degree - 34 L, CE	66037018	FDA UDI	Class II	Active
Mondial 8, A4 / 33 U, CE	66017335	FDA UDI	Class II	Active
Artic 8, B3 / 20 degree - 34 L, CE	66014164	FDA UDI	Class II	Active
Mondial 6, B2 / T405, CE	66017016	FDA UDI	Class II	Active
Mondial 6i, A1 / T4, CE	66970463	FDA UDI	Class II	Active
Mondial 8, A2 / 33 U, CE	66017305	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