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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 120 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8, C4 / 29 U, CE	66017411	FDA UDI	Class II	Active
Delara	66071404	FDA UDI	Class II	Active
Artic digital 6, B3 / O10D, CE	66080412	FDA UDI	Class II	Active
Delara	66071502	FDA UDI	Class II	Active
Mondial 8, BL3 / 35 U, CE	66801130	FDA UDI	Class II	Active
Mondial 6, B1 / L373, CE	66017006	FDA UDI	Class II	Active
Flexitime Correct Flow 1 X 50 Ml Sample	66003641	FDA UDI	Class II	Active
Mondial 6, BL2 / T495, CE	66975589	FDA UDI	Class II	Active
Basic 6, C4 / U05, CE	56739317	FDA UDI	Class II	Unknown
Basic 6, C1 / L01, CE	56739074	FDA UDI	Class II	Unknown
Mondial 6, A4 / L369, CE	66016977	FDA UDI	Class II	Active
Delara	66071669	FDA UDI	Class II	Active
Artic 6, D2 / L 15, CE	66015063	FDA UDI	Class II	Active
Artic	66080488	FDA UDI	Class II	Active
Mondial 6, B1 / R420, CE	66016984	FDA UDI	Class II	Active
Artic	66080586	FDA UDI	Class II	Active
Artic	66080684	FDA UDI	Class II	Active
Premium 6, BL3 / R6, CE	66802950	FDA UDI	Class II	Unknown
Flexitime	66099320	FDA UDI	Class II	Active
Basic 6, C2 / P21, CE	56739203	FDA UDI	Class II	Unknown
Artic 6, B4 / T 30, CE	66014021	FDA UDI	Class II	Active
Mondial 8i, BL3 / 31L, CE	66973865	FDA UDI	Class II	Active
Mondial 6 DS, A2 / T450, CE	66985627	FDA UDI	Class II	Unknown
Mondial 8i, C1 / 31 U, CE	66973872	FDA UDI	Class II	Active
Mondial 6, B3 / T495, CE	66975573	FDA UDI	Class II	Active
Artic 8, D3 / 30 degree - 30 U, CE	66037079	FDA UDI	Class II	Active
Mondial 8i, D3 / 37 U, CE	66973918	FDA UDI	Class II	Active
Mondial 8i, B2 / 35L, CE	66973837	FDA UDI	Class II	Active
Dima	66081679	FDA UDI	Class II	Active
Artic 8, A2 / 0 degree - 32 U, CE	66015111	FDA UDI	Class II	Active
Mondial 6, B2 / S451, CE	66975559	FDA UDI	Class II	Active
Artic 6, D2 / L 50, CE	66014115	FDA UDI	Class II	Active
Mondial 6, A4 / S451, CE	66975543	FDA UDI	Class II	Active
Mondial 6, A4 / T435, CE	66975546	FDA UDI	Class II	Active
Mondial 6, D3 / T452, CE	66975644	FDA UDI	Class II	Active
Artic 6, B2 / L 45, CE	66014953	FDA UDI	Class II	Active
Artic digital 6, B3 / L25D, CE	66983086	FDA UDI	Class II	Active
Mondial 8i, B4 / S, CE	66970920	FDA UDI	Class II	Active
Mondial 6 DS, A2 / T452, CE	66985628	FDA UDI	Class II	Unknown
Artic digital 8, B3 / 10 degrees-32LD, CE	66080709	FDA UDI	Class II	Active
Artic	66080628	FDA UDI	Class II	Active
Delara	66071394	FDA UDI	Class II	Active
Artic	66080547	FDA UDI	Class II	Active
Premium 8, C3 / L, CE	66007198	FDA UDI	Class II	Unknown
Mondial 6i, D4 / L18, CE	66970849	FDA UDI	Class II	Active
Mondial 6i, C4 / R6, CE	66970768	FDA UDI	Class II	Active
Premium 6, B1 / L14, CE	66006918	FDA UDI	Class II	Unknown
Delara	66071408	FDA UDI	Class II	Active
Mondial 6, C1 / T435, CE	66975602	FDA UDI	Class II	Active
Mondial 6, D4 / L373, CE	66017286	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