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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 20 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8, A2 / 29 U, CE	66017301	FDA UDI	Class II	Active
Mondial 6, C2 / S451, CE	66975607	FDA UDI	Class II	Active
Mondial 8i, B1 / 31L, CE	66973825	FDA UDI	Class II	Active
Mondial 6i DS, B1 / L22, CE	66986349	FDA UDI	Class II	Unknown
Dima	66077052	FDA UDI	Class II	Active
Mondial 6, BL3 / S550, CE	66975593	FDA UDI	Class II	Active
Artic	66080327	FDA UDI	Class II	Active
Signum composite flow	66048945	FDA UDI	Class II	Active
Mondial 6i, C3 / R8, CE	66970747	FDA UDI	Class II	Active
Durafill VS	66000028	FDA UDI	Class II	Active
Basic 6, A3.5 / L04, CE	56739116	FDA UDI	Class II	Unknown
Delara	66071548	FDA UDI	Class II	Active
Basic 6, A3 / P20, CE	56739179	FDA UDI	Class II	Unknown
Delara	66071355	FDA UDI	Class II	Active
Delara	66071274	FDA UDI	Class II	Active
Mondial 8, C1 / 30L, CE	66802161	FDA UDI	Class II	Active
Premium 6, D3 / T4, CE	66007169	FDA UDI	Class II	Unknown
Mondial 6i, BL2 / T6, CE	66970662	FDA UDI	Class II	Active
Delara	66071512	FDA UDI	Class II	Active
Artic 8, B1 / 20 degree - 30 U, CE	66012935	FDA UDI	Class II	Active
Mondial 8i, A3.5 / 31 U, CE	66973808	FDA UDI	Class II	Active
Artic 8, A1 / 20 degree - 32 L, CE	66012952	FDA UDI	Class II	Active
Mondial 6i, C3 / L22, CE	66970764	FDA UDI	Class II	Active
Mondial 6i, C3 / T6, CE	66970750	FDA UDI	Class II	Active
Artic digital 6, D3 / L25D, CE	66983174	FDA UDI	Class II	Active
Artic 8, C3 / 20 degree - 34 L, CE	66014167	FDA UDI	Class II	Active
Premium 6, A2 / S2, CE	66007092	FDA UDI	Class II	Unknown
Artic 8, BL3 / 10 degree - 30 U, CE	66970446	FDA UDI	Class II	Active
Artic digital 6, A3 / T35D, CE	66080311	FDA UDI	Class II	Active
Delara	66071320	FDA UDI	Class II	Active
Mondial 6, D2 / T450, CE	66017214	FDA UDI	Class II	Active
Flexitime	66099319	FDA UDI	Class II	Active
Artic 8, C2 / 30 degree - 34 U, CE	66037059	FDA UDI	Class II	Active
Artic 6, D4 / S 30, CE	66013991	FDA UDI	Class II	Active
Mondial 6 DS, A3.5 / S443, CE	66985689	FDA UDI	Class II	Unknown
Mondial 6i, C2 / L16, CE	66970738	FDA UDI	Class II	Active
Artic digital 8, A1 / 20 degree-36LD, CE	66983192	FDA UDI	Class II	Active
Mondial 8i, C3 / SL, CE	66970961	FDA UDI	Class II	Active
Mondial 6i, BL2 / L19, CE	66970674	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 1x10x0, 25G HKA5	66039014	FDA UDI	Class II	Active
Palaseal, 1000 ml	64710614	FDA UDI	Class II	Unknown
Artic digital 6, B4 / R30D, CE	66983090	FDA UDI	Class II	Active
Premium 6, C4 / T4, CE	66007167	FDA UDI	Class II	Unknown
Artic 8, C3 / 0 degree - 32 L, CE	66015212	FDA UDI	Class II	Active
Premium 6, D3 / L12, CE	66006911	FDA UDI	Class II	Unknown
Artic digital 6, A3.5 / T15D, CE	66080331	FDA UDI	Class II	Active
Basic 6, D3 / A11, CE	56739031	FDA UDI	Class II	Unknown
Artic digital 6, C4 / L20D, CE	66983151	FDA UDI	Class II	Active
Mondial 8, B3 / 35L, CE	66017368	FDA UDI	Class II	Active
FLEXITIME DYNAMIX PUTTY REFILL1X(2X380ml	60035991	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