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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 112 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6, BL2 / S453, CE	66801031	FDA UDI	Class II	Active
Premium 8, A3.5 / L, CE	66007190	FDA UDI	Class II	Unknown
Premium 6, A3.5 / L12, CE	66006900	FDA UDI	Class II	Unknown
Basic 6, B3 / A13, CE	56739056	FDA UDI	Class II	Unknown
Basic 6, D4 / L05, CE	56739144	FDA UDI	Class II	Unknown
Basic 8, D2 / BO, CE	56739414	FDA UDI	Class II	Unknown
Basic 6, C1 / L02, CE	56739090	FDA UDI	Class II	Unknown
Mondial 6, D2 / T442, CE	66017213	FDA UDI	Class II	Active
Artic 6, C2 / L 25, CE	66015016	FDA UDI	Class II	Active
Flow Line Syr 2 X 1 Ml - A3, 5	66000760	FDA UDI	Class II	Unknown
Mondial 6i, A1 / R8, CE	66970461	FDA UDI	Class II	Active
Mondial 8i, C1 / SL, CE	66970945	FDA UDI	Class II	Active
Artic digital 6, B4 / TO20D, CE	66983095	FDA UDI	Class II	Active
Artic 6, B4 / R 20, CE	66014972	FDA UDI	Class II	Active
Mondial 6, A3.5 / L373, CE	66016950	FDA UDI	Class II	Active
Mondial 6, C4 / T450, CE	66017186	FDA UDI	Class II	Active
Delara	66071338	FDA UDI	Class II	Active
Artic 6, B3 / T 35, CE	66014962	FDA UDI	Class II	Active
Delara	66071649	FDA UDI	Class II	Active
Delara	66071487	FDA UDI	Class II	Active
Premium 6, C4 / L18, CE	66006957	FDA UDI	Class II	Unknown
Mondial 6, B4 / L315, CE	66017085	FDA UDI	Class II	Active
Premium 8, A2 / XS, CE	66007284	FDA UDI	Class II	Unknown
Artic 6, B2 / O 10, CE	66012873	FDA UDI	Class II	Active
Mondial 8, C3 / 32L, CE	66802175	FDA UDI	Class II	Active
Palabond, 45 ml	64708082	FDA UDI	Class II	Active
Basic 6, A3 / U07, CE	56739339	FDA UDI	Class II	Unknown
Mondial 8, B1 / 37 U, CE	66017349	FDA UDI	Class II	Active
Mondial 6i, C2 / S4, CE	66970733	FDA UDI	Class II	Active
Mondial 6i, B1 / R8, CE	66970571	FDA UDI	Class II	Active
Delara	66071482	FDA UDI	Class II	Active
Mondial 6, BL3 / L315, CE	66801066	FDA UDI	Class II	Active
Mondial 8, A3 / 30L, CE	66802119	FDA UDI	Class II	Active
Artic digital 6, C2 / TO10D, CE	66080490	FDA UDI	Class II	Active
Basic 6, D4 / U02, CE	56739272	FDA UDI	Class II	Unknown
Mondial 8i, B2 / XS, CE	66970902	FDA UDI	Class II	Active
Mondial 6i, C1 / S8, CE	66970713	FDA UDI	Class II	Active
Mondial 8, B2 / 30L, CE	66802143	FDA UDI	Class II	Active
Artic digital 8, B3 / 20 degree-34 UD, CE	66983231	FDA UDI	Class II	Active
Artic	66080308	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 2x10x0, 25G B1	66039015	FDA UDI	Class II	Active
Artic digital 6, B3 / TO05D, CE	66080423	FDA UDI	Class II	Active
Artic	66080261	FDA UDI	Class II	Active
Delara	66071351	FDA UDI	Class II	Active
Premium 6, A4 / O4, CE	66007015	FDA UDI	Class II	Unknown
Artic digital 8, C1 / 20 degree-36 UD, CE	66983251	FDA UDI	Class II	Active
Artic 6, C4 / S 05, CE	66015039	FDA UDI	Class II	Active
Artic 8, A3.5 / 20 degree - 36 U, CE	66015137	FDA UDI	Class II	Active
Artic 6, A3.5 / S 20, CE	66012822	FDA UDI	Class II	Active
Basic 6, A3.5 / P23, CE	56739228	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