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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 100 of 123

Device	Model / Reference	Registries	Class	Status
FLEXITIME DYN.MONOPHASE PRO SCAN 2x380ML	66045801	FDA UDI	Class II	Unknown
Durafill VS	66000022	FDA UDI	Class II	Active
Premium 6, A4 / R6, CE	66007079	FDA UDI	Class II	Unknown
Artic 6, A4 / T 30, CE	66014019	FDA UDI	Class II	Active
Artic 6, D4 / L 15, CE	66015095	FDA UDI	Class II	Active
Premium 8, BL2 / M, CE	66802996	FDA UDI	Class II	Unknown
Mondial 8, A4 / 31 U, CE	66017333	FDA UDI	Class II	Active
Basic 8, B3 / DO, CE	56739472	FDA UDI	Class II	Unknown
Premium 6, BL2 / T2, CE	66802933	FDA UDI	Class II	Unknown
Basic 6, A3.5 / L05, CE	56739132	FDA UDI	Class II	Unknown
Artic 6, BL3 / T 35, CE	66970427	FDA UDI	Class II	Active
Mondial 6i, B3 / S4, CE	66970623	FDA UDI	Class II	Active
Artic 6, B3 / TO 30, CE	66014056	FDA UDI	Class II	Active
Mondial 6i, A4 / L16, CE	66970562	FDA UDI	Class II	Active
VENUS Diamond FLOW SYR 1 x 1, 8G - HKA5	66040361	FDA UDI	Class II	Active
Artic 8, A4 / 20 degree - 34 U, CE	66014154	FDA UDI	Class II	Active
Artic 6, C3 / TO 30, CE	66014059	FDA UDI	Class II	Active
Basic 6, A3 / U05, CE	56739307	FDA UDI	Class II	Unknown
Premium 6, A2 / R4, CE	66007060	FDA UDI	Class II	Unknown
Artic 8, B4 / 0 degree - 30 L, CE	66015180	FDA UDI	Class II	Active
Premium 6, B2 / T4, CE	66007161	FDA UDI	Class II	Unknown
Basic 6, D3 / U07, CE	56739351	FDA UDI	Class II	Unknown
Mondial 8, D4 / 33L, CE	66017446	FDA UDI	Class II	Active
Artic 8, B4 / 30 degree - 34 L, CE	66037048	FDA UDI	Class II	Active
Basic 8, C3 / BO, CE	56739412	FDA UDI	Class II	Unknown
Artic	66080704	FDA UDI	Class II	Active
Artic digital 8, C1 / 20 degree-32 UD, CE	66983247	FDA UDI	Class II	Active
Mondial 8, A1 / 30L, CE	66802107	FDA UDI	Class II	Active
Artic digital 6, B2 / L25D, CE	66983075	FDA UDI	Class II	Active
Mondial 6i, D4 / S6, CE	66970844	FDA UDI	Class II	Active
Mondial 8, D4 / 37 U, CE	66017449	FDA UDI	Class II	Active
Premium 6, B3 / L16, CE	66006936	FDA UDI	Class II	Unknown
Basic 8, C2 / FU, CE	56739619	FDA UDI	Class II	Unknown
Artic digital 6, A1 / O10D, CE	66080258	FDA UDI	Class II	Active
Delara	66071332	FDA UDI	Class II	Active
Artic 8, A3 / 30 degree - 30 L, CE	66037008	FDA UDI	Class II	Active
Artic 6, A3 / O 10, CE	66012870	FDA UDI	Class II	Active
Basic 6, A3 / U03, CE	56739275	FDA UDI	Class II	Unknown
Artic 8, B4 / 10 degree - 32 U, CE	66015185	FDA UDI	Class II	Active
Pala	66079658	FDA UDI	Class I	Unknown
Delara	66071224	FDA UDI	Class II	Active
Delara	66071160	FDA UDI	Class II	Active
Basic 6, A4 / P21, CE	56739197	FDA UDI	Class II	Unknown
Basic 8, B3 / HU, CE	56739552	FDA UDI	Class II	Unknown
Artic	66080306	FDA UDI	Class II	Active
Mondial 6, B3 / L384, CE	66017065	FDA UDI	Class II	Active
Premium 8, D2 / S, CE	66007264	FDA UDI	Class II	Unknown
Basic 8, C1 / HO, CE	56739538	FDA UDI	Class II	Unknown
Charisma	66000086	FDA UDI	Class II	Active
Premium 6, BL3 / R2, CE	66802948	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