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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 86 of 123

Device	Model / Reference	Registries	Class	Status
Charisma ABC	66064774	FDA UDI	Class II	Active
Artic digital 6, A4 / TO10D, CE	66080358	FDA UDI	Class II	Active
Mondial 8i, B3 / 31 U, CE	66973840	FDA UDI	Class II	Active
Artic digital 6, D2 / S30D, CE	66983158	FDA UDI	Class II	Active
Artic digital 8, B4 / 20 degree-36 UD, CE	66983239	FDA UDI	Class II	Active
Mondial 6i, C4 / L16, CE	66970782	FDA UDI	Class II	Active
Mondial 6, C1 / T495, CE	66975605	FDA UDI	Class II	Active
Artic 6, B3 / L 45, CE	66014969	FDA UDI	Class II	Active
CHARISMA SYR 1 x 4G - C3	66000094	FDA UDI	Class II	Active
Premium 6, C1 / L22, CE	66006987	FDA UDI	Class II	Unknown
Artic	66080765	FDA UDI	Class II	Active
Mondial 6i, BL3 / S4, CE	66970689	FDA UDI	Class II	Active
Artic	66080664	FDA UDI	Class II	Active
Artic 6, C2 / S 35, CE	66015008	FDA UDI	Class II	Active
Artic 8, A1 / 10 degree - 32 L, CE	66015106	FDA UDI	Class II	Active
Artic 8, D3 / 20 degree - 30 L, CE	66014134	FDA UDI	Class II	Active
Artic 6, D4 / T 10, CE	66014009	FDA UDI	Class II	Active
Mondial 6, B1 / S550, CE	66975553	FDA UDI	Class II	Active
Mondial 8i DS, A3.5 / 35L, CE	66986854	FDA UDI	Class II	Unknown
Memosil 2 1 X (2 X 50 Ml)	50035018	FDA UDI	Class II	Active
Mondial 6, C2 / R520, CE	66975606	FDA UDI	Class II	Active
Mondial 6, BL3 / S443, CE	66801057	FDA UDI	Class II	Active
Mondial 6, C4 / T465, CE	66017187	FDA UDI	Class II	Active
Mondial 8, D4 / 35 U, CE	66017447	FDA UDI	Class II	Active
Mondial 8, B3 / 33L, CE	66017366	FDA UDI	Class II	Active
Mondial 6, D4 / L369, CE	66017285	FDA UDI	Class II	Active
Artic digital 6, D4 / T20D, CE	66080596	FDA UDI	Class II	Active
Artic 8, C2 / 20 degree - 30 U, CE	66012937	FDA UDI	Class II	Active
Artic digital 6, D3 / TO10D, CE	66080578	FDA UDI	Class II	Active
Delara	66071668	FDA UDI	Class II	Active
Mondial 6, B1 / T515, CE	66016993	FDA UDI	Class II	Active
Artic	66080792	FDA UDI	Class II	Active
Mondial 8, D4 / 28L, CE	66802195	FDA UDI	Class II	Active
VENUS Diamond FLOW PLT 20x0, 20g - A2	66040369	FDA UDI	Class II	Active
Artic 6, D4 / L 45, CE	66015097	FDA UDI	Class II	Active
Delara	66071514	FDA UDI	Class II	Active
Delara	66071433	FDA UDI	Class II	Active
Mondial 6, A2 / O525, CE	66016885	FDA UDI	Class II	Active
Artic 8, BL3 / 20 degree - 32 L, CE	66970439	FDA UDI	Class II	Active
Artic digital 6, B1 / O30D, CE	66983055	FDA UDI	Class II	Active
Mondial 8i, B3 / S, CE	66970912	FDA UDI	Class II	Active
Artic digital 6, C4 / O30D, CE	66983143	FDA UDI	Class II	Active
Mondial 6i, D3 / L24, CE	66970831	FDA UDI	Class II	Active
Premium 6, A3 / T6, CE	66007173	FDA UDI	Class II	Unknown
Artic digital 6, C2 / TO40D, CE	66080492	FDA UDI	Class II	Active
Mondial 6i, B2 / L19, CE	66970608	FDA UDI	Class II	Active
Artic digital 8, A3.5 / 20 degrees-30LD, CE	66080671	FDA UDI	Class II	Active
Venus Pearl	66048190	FDA UDI	Class II	Active
Mondial 8i, B2 / 37L, CE	66973839	FDA UDI	Class II	Active
Delara	66071231	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