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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 87 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8, B3 / 30L, CE	66802149	FDA UDI	Class II	Active
Dima	66081678	FDA UDI	Class II	Active
Artic	66080607	FDA UDI	Class II	Active
Delara	66071535	FDA UDI	Class II	Active
Mondial 8, C1 / 35 U, CE	66017387	FDA UDI	Class II	Active
Artic 6, A3.5 / R 30, CE	66014893	FDA UDI	Class II	Active
Premium 6, C2 / L18, CE	66006955	FDA UDI	Class II	Unknown
Delara	66071329	FDA UDI	Class II	Active
Mondial 8, C1 / 31 U, CE	66017383	FDA UDI	Class II	Active
VENUS DIAMOND PLT REFILL 1x10x0, 25G CL	66039027	FDA UDI	Class II	Active
Mondial 6, A3 / S443, CE	66016914	FDA UDI	Class II	Active
Artic digital 8, BL3 / 10 degrees-30 UD, CE	66080796	FDA UDI	Class II	Active
Artic 6, B4 / T 20, CE	66014012	FDA UDI	Class II	Active
Artic digital 6, D4 / R30D, CE	66983178	FDA UDI	Class II	Active
Basic 8, D2 / DO, CE	56739478	FDA UDI	Class II	Unknown
Mondial 8i, BL2 / LL, CE	66970933	FDA UDI	Class II	Active
Artic digital 6, B2 / O30D, CE	66983066	FDA UDI	Class II	Active
Artic 8, A1 / 20 degree - 32 U, CE	66012945	FDA UDI	Class II	Active
Venus Pearl	66096882	FDA UDI	Class II	Active
Basic 6, A3.5 / U03, CE	56739276	FDA UDI	Class II	Unknown
Mondial 8i, C4 / ML, CE	66970971	FDA UDI	Class II	Active
Mondial 8, D3 / 37 U, CE	66017439	FDA UDI	Class II	Active
Mondial 6, C4 / S453, CE	66017196	FDA UDI	Class II	Active
Artic 6, B1 / S 35, CE	66014928	FDA UDI	Class II	Active
Artic 6, D4 / S 10, CE	66013973	FDA UDI	Class II	Active
Premium 6, D2 / L14, CE	66006926	FDA UDI	Class II	Unknown
Premium 8, A3.5 / ML, CE	66007238	FDA UDI	Class II	Unknown
Venus Diamond	66096875	FDA UDI	Class II	Active
Mondial 6, C3 / L341, CE	66017171	FDA UDI	Class II	Active
Mondial 8, B3 / 32L, CE	66802151	FDA UDI	Class II	Active
Basic 8, C4 / GO, CE	56739509	FDA UDI	Class II	Unknown
Basic 8, A1 / DO, CE	56739465	FDA UDI	Class II	Unknown
Artic 6, B2 / L 15, CE	66014951	FDA UDI	Class II	Active
Delara	66071151	FDA UDI	Class II	Active
Mondial 8, C3 / 37 U, CE	66017409	FDA UDI	Class II	Active
Mondial 8, D4 / 31 U, CE	66017443	FDA UDI	Class II	Active
Artic digital 6, D4 / S30D, CE	66983180	FDA UDI	Class II	Active
Premium 6, C2 / R2, CE	66007053	FDA UDI	Class II	Unknown
Mondial 6i, D4 / O6, CE	66970841	FDA UDI	Class II	Active
Artic digital 8, A3.5 / 20 degree-34 UD, CE	66983207	FDA UDI	Class II	Active
Mondial 6i, D3 / S6, CE	66970822	FDA UDI	Class II	Active
Premium 6, C1 / L14, CE	66006922	FDA UDI	Class II	Unknown
Premium 6, BL2 / L20, CE	66802946	FDA UDI	Class II	Unknown
Premium 8, A1 / S, CE	66007251	FDA UDI	Class II	Unknown
Mondial 6 DS, B1 / T495, CE	66985775	FDA UDI	Class II	Unknown
Flexitime Fast&Scan Dyn. Ht & Flow Trial	66045793	FDA UDI	Class II	Unknown
Delara	66071211	FDA UDI	Class II	Active
Mondial 8i DS, B1 / 31L, CE	66986882	FDA UDI	Class II	Unknown
Basic 8, D3 / EU, CE	56739591	FDA UDI	Class II	Unknown
Artic	66080325	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