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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 4 of 123

Device	Model / Reference	Registries	Class	Status
Artic 6, A4 / T 10, CE	66014001	FDA UDI	Class II	Active
Artic 6, B1 / L 10, CE	66012900	FDA UDI	Class II	Active
Basic 6, C3 / A10, CE	56739012	FDA UDI	Class II	Unknown
Mondial 6i, A4 / L12, CE	66970560	FDA UDI	Class II	Active
Artic digital 6, A2 / R40D, CE	66983014	FDA UDI	Class II	Active
Mondial 6i, B3 / O6, CE	66970621	FDA UDI	Class II	Active
Artic 6, D4 / T 30, CE	66014027	FDA UDI	Class II	Active
Basic 8, C4 / DO, CE	56739477	FDA UDI	Class II	Unknown
Mondial 6, D3 / O457, CE	66017247	FDA UDI	Class II	Active
Basic 6, C1 / P20, CE	56739186	FDA UDI	Class II	Unknown
Mondial 6, A1 / O444, CE	66016853	FDA UDI	Class II	Active
Mondial 8, A4 / 32L, CE	66802133	FDA UDI	Class II	Active
Basic 8, B2 / EO, CE	56739567	FDA UDI	Class II	Unknown
Mondial 6i, C3 / R4, CE	66970745	FDA UDI	Class II	Active
Mondial/Mondial I Living Mould Chart B1	40005810	FDA UDI	Class II	Active
Premium 6, A2 / S4, CE	66007108	FDA UDI	Class II	Unknown
Basic 6, A2 / L06, CE	56739146	FDA UDI	Class II	Unknown
Basic 6, A1 / L01, CE	56739065	FDA UDI	Class II	Unknown
Artic digital 6, D4 / TO20D, CE	66983183	FDA UDI	Class II	Active
Basic 6, A2 / U01, CE	56739242	FDA UDI	Class II	Unknown
Artic	66080460	FDA UDI	Class II	Active
Artic digital 6, D4 / T30D, CE	66983182	FDA UDI	Class II	Active
Mondial 8i, C2 / XSL, CE	66970951	FDA UDI	Class II	Active
Mondial 8i, B4 / L, CE	66970924	FDA UDI	Class II	Active
Mondial 6i DS, A1 / R4, CE	66986220	FDA UDI	Class II	Unknown
Artic 6, C2 / S 10, CE	66012818	FDA UDI	Class II	Active
Mondial 8i, C2 / L, CE	66970956	FDA UDI	Class II	Active
Mondial 8i, C4 / LL, CE	66970973	FDA UDI	Class II	Active
Mondial 8, D3 / 32L, CE	66802193	FDA UDI	Class II	Active
Mondial 6i, B2 / O6, CE	66970599	FDA UDI	Class II	Active
Artic 6, D4 / S 40, CE	66014000	FDA UDI	Class II	Active
Delara	66071294	FDA UDI	Class II	Active
Mondial 6, A1 / L341, CE	66016862	FDA UDI	Class II	Active
VENUS FLOW SYR 1 x 1, 8G - B2	66014568	FDA UDI	Class II	Active
Artic 8, A3.5 / 20 degree - 32 U, CE	66012948	FDA UDI	Class II	Active
Premium 6, C3 / L14, CE	66006924	FDA UDI	Class II	Unknown
Mondial 8i, BL3 / S, CE	66970936	FDA UDI	Class II	Active
Mondial 8i, A1 / XSL, CE	66970855	FDA UDI	Class II	Active
Artic digital 8, C4 / 20 degree-32 UD, CE	66983265	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 1x10x0, 25G B3	66039017	FDA UDI	Class II	Active
Artic digital 6, A4 / L05D, CE	66080361	FDA UDI	Class II	Active
Delara	66071532	FDA UDI	Class II	Active
Artic digital 6, BL3 / TO20D, CE	66983106	FDA UDI	Class II	Active
Basic 6, A2 / U05, CE	56739306	FDA UDI	Class II	Unknown
Basic 6, D3 / A13, CE	56739063	FDA UDI	Class II	Unknown
Mondial 6 DS, A3.5 / R520, CE	66985688	FDA UDI	Class II	Unknown
Basic 8, C3 / FU, CE	56739620	FDA UDI	Class II	Unknown
Mondial 6i, A3 / R6, CE	66970504	FDA UDI	Class II	Active
Artic 6, D3 / T 40, CE	66014035	FDA UDI	Class II	Active
Mondial 6i DS, A3.5 / R4, CE	66986286	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