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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 110 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071253	FDA UDI	Class II	Active
Delara	66071172	FDA UDI	Class II	Active
Premium 6, B4 / L14, CE	66006921	FDA UDI	Class II	Unknown
Artic 6, B1 / S 40, CE	66012837	FDA UDI	Class II	Active
Mondial 6i, B4 / S6, CE	66970646	FDA UDI	Class II	Active
Artic digital 6, A1 / TO10D, CE	66080270	FDA UDI	Class II	Active
Artic	66080422	FDA UDI	Class II	Active
Mondial 8i, C2 / M, CE	66970954	FDA UDI	Class II	Active
Mondial 6i, C2 / S2, CE	66970732	FDA UDI	Class II	Active
Mondial 6i, A3.5 / R6, CE	66970526	FDA UDI	Class II	Active
Artic digital 8, B2 / 20 degree-32 UD, CE	66983223	FDA UDI	Class II	Active
Mondial 8i, B3 / XSL, CE	66970911	FDA UDI	Class II	Active
Artic 6, B2 / R 20, CE	66014940	FDA UDI	Class II	Active
Mondial 6, A3 / R449, CE	66016901	FDA UDI	Class II	Active
Mondial 6, C3 / R483, CE	66017155	FDA UDI	Class II	Active
Mondial 8, D4 / 29L, CE	66017442	FDA UDI	Class II	Active
Artic 6, B2 / TO 40, CE	66012894	FDA UDI	Class II	Active
Durafill VS	66000015	FDA UDI	Class II	Active
Mondial 6, B1 / T442, CE	66016989	FDA UDI	Class II	Active
Basic 6, A2 / P22, CE	56739210	FDA UDI	Class II	Unknown
Mondial 6 DS, A3 / T515, CE	66985668	FDA UDI	Class II	Unknown
Mondial 6 DS, A3.5 / R449, CE	66985685	FDA UDI	Class II	Unknown
Dima	66077053	FDA UDI	Class II	Unknown
Basic 6, C3 / P23, CE	56739236	FDA UDI	Class II	Unknown
Mondial 6 DS, A1 / L331, CE	66985598	FDA UDI	Class II	Unknown
Mondial 6 DS, A3 / L382, CE	66985676	FDA UDI	Class II	Unknown
Artic digital 6, B3 / R20D, CE	66983078	FDA UDI	Class II	Active
Delara	66071579	FDA UDI	Class II	Active
Mondial 8 DS, A3.5 / 37L, CE	66986654	FDA UDI	Class II	Unknown
Mondial 6, A4 / S453, CE	66016972	FDA UDI	Class II	Active
Mondial 6, B2 / S550, CE	66975561	FDA UDI	Class II	Active
Memoreg 2 1 X (2 X 50 Ml)	66004965	FDA UDI	Class II	Active
Basic 8, C2 / EU, CE	56739587	FDA UDI	Class II	Unknown
Artic 8, A1 / 0 degree - 30 U, CE	66015099	FDA UDI	Class II	Active
Premium 6, B2 / S2, CE	66007097	FDA UDI	Class II	Unknown
Basic 8, D4 / DU, CE	56739496	FDA UDI	Class II	Unknown
VENUS DIAMOND SYRINGE REFILL 1x4G C3	66035482	FDA UDI	Class II	Active
Premium 8, A4 / XS, CE	66007287	FDA UDI	Class II	Unknown
Artic digital 6, A2 / TO10D, CE	66080292	FDA UDI	Class II	Active
Delara	66071642	FDA UDI	Class II	Active
Delara	66071453	FDA UDI	Class II	Active
Basic 6, D4 / U03, CE	56739288	FDA UDI	Class II	Unknown
Artic digital 8, A1 / 20 degrees-30 UD, CE	66080640	FDA UDI	Class II	Active
Mondial 6, D4 / R420, CE	66017264	FDA UDI	Class II	Active
FLEXITIME DYNAMIX HT REFILL 1X(2X380ml)	60035992	FDA UDI	Class II	Active
Mondial 8, A3 / 35L, CE	66017318	FDA UDI	Class II	Active
Mondial 6, B4 / T465, CE	66017075	FDA UDI	Class II	Active
Delara	66071244	FDA UDI	Class II	Active
Premium 8, C4 / ML, CE	66007247	FDA UDI	Class II	Unknown
Mondial 6, C4 / O444, CE	66017190	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