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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 13 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 8, D4 / 35L, CE	66017448	FDA UDI	Class II	Active
Artic digital 8, BL3 / 20 degree-32LD, CE	66983242	FDA UDI	Class II	Active
Mondial 6i DS, A3 / O2, CE	66986270	FDA UDI	Class II	Unknown
Delara	66071364	FDA UDI	Class II	Active
Artic digital 6, B4 / TO10D, CE	66080446	FDA UDI	Class II	Active
Artic	66080365	FDA UDI	Class II	Active
Delara	66071536	FDA UDI	Class II	Active
Artic digital 8, D4 / 10 degrees-32 UD, CE	66080788	FDA UDI	Class II	Active
Delara	66071553	FDA UDI	Class II	Active
Venus Pearl	66048144	FDA UDI	Class II	Active
Basic 8, C1 / BO, CE	56739410	FDA UDI	Class II	Unknown
ST Basic 6, CE	66030384	FDA UDI	Class II	Active
Mondial 6, B2 / L382, CE	66017036	FDA UDI	Class II	Active
Artic digital 6, D2 / T35D, CE	66080553	FDA UDI	Class II	Active
Artic 6, C1 / L 15, CE	66014999	FDA UDI	Class II	Active
Dima	66087419	FDA UDI	Class II	Active
Delara	66071339	FDA UDI	Class II	Active
Delara	66071258	FDA UDI	Class II	Active
Mondial 6i, BL2 / L22, CE	66970676	FDA UDI	Class II	Active
Mondial 8i, B1 / M, CE	66970898	FDA UDI	Class II	Active
Mondial 6, A3 / L369, CE	66016921	FDA UDI	Class II	Active
Mondial 6i, B4 / L14, CE	66970649	FDA UDI	Class II	Active
Delara	66071528	FDA UDI	Class II	Active
Mondial 8i, A3 / ML, CE	66970875	FDA UDI	Class II	Active
Artic 6, C3 / O 30, CE	66015019	FDA UDI	Class II	Active
Mondial 6 DS, A3 / S443, CE	66985653	FDA UDI	Class II	Unknown
Artic digital 6, B1 / S30D, CE	66983059	FDA UDI	Class II	Active
Dima	66077057	FDA UDI	Class II	Active
Mondial 8i, A3.5 / 35 U, CE	66973812	FDA UDI	Class II	Active
Mondial 6i, D4 / S2, CE	66970842	FDA UDI	Class II	Active
Premium 6, A1 / L16, CE	66006929	FDA UDI	Class II	Unknown
Artic 8, B4 / 10 degree - 32 L, CE	66015186	FDA UDI	Class II	Active
Durafill VS	66000017	FDA UDI	Class II	Active
Premium 6, BL2 / T4, CE	66802934	FDA UDI	Class II	Unknown
Flexitime	66099321	FDA UDI	Class II	Active
Signum composite flow	66048942	FDA UDI	Class II	Active
Premium 6, C4 / O6, CE	66007039	FDA UDI	Class II	Unknown
Mondial 6, A2 / T465, CE	66016879	FDA UDI	Class II	Active
Venus Bulk Flow ONE	66094724	FDA UDI	Class II	Active
Artic 8, B3 / 30 degree - 32 L, CE	66037040	FDA UDI	Class II	Active
Delara	66071183	FDA UDI	Class II	Active
Premium 6, B1 / L18, CE	66006950	FDA UDI	Class II	Unknown
Mondial 6i, BL2 / S6, CE	66970668	FDA UDI	Class II	Active
Mondial 6 DS, A2 / S453, CE	66985620	FDA UDI	Class II	Unknown
Premium 6, BL2 / L14, CE	66802943	FDA UDI	Class II	Unknown
Mondial 8 DS, A3.5 / 31L, CE	66986648	FDA UDI	Class II	Unknown
Mondial 8, C2 / 33L, CE	66017396	FDA UDI	Class II	Active
Artic 6, A3 / TO 20, CE	66014885	FDA UDI	Class II	Active
Mondial 8i DS, A3.5 / 37L, CE	66986856	FDA UDI	Class II	Unknown
Paladon 65, pink, 1000 g	64707706	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