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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 10 of 123

Device	Model / Reference	Registries	Class	Status
Premium 8, C4 / LL, CE	66007215	FDA UDI	Class II	Unknown
Mondial 6, A4 / S443, CE	66016970	FDA UDI	Class II	Active
Artic 6, B3 / R 30, CE	66014957	FDA UDI	Class II	Active
Venus Bulk Fill Syr Pediatric Kit + Ibse	66057342	FDA UDI	Class II	Unknown
Artic digital 8, C3 / 20 degrees-30LD, CE	66080751	FDA UDI	Class II	Active
Mondial 8, B1 / 30L, CE	66802137	FDA UDI	Class II	Active
Artic 8, A2 / 0 degree - 30 U, CE	66015109	FDA UDI	Class II	Active
Artic 6, C2 / L 10, CE	66012902	FDA UDI	Class II	Active
Premium 6, C3 / R4, CE	66007070	FDA UDI	Class II	Unknown
Premium 6, A1 / S4, CE	66007107	FDA UDI	Class II	Unknown
Mondial 6, D2 / T405, CE	66017212	FDA UDI	Class II	Active
Artic 6, C4 / L 25, CE	66015048	FDA UDI	Class II	Active
Artic digital 6, A4 / T30D, CE	66983050	FDA UDI	Class II	Active
Artic	66080733	FDA UDI	Class II	Active
Venus Pearl	66048090	FDA UDI	Class II	Active
Delara	66071178	FDA UDI	Class II	Active
Artic 6, B4 / TO 20, CE	66014981	FDA UDI	Class II	Active
Artic	66080613	FDA UDI	Class II	Active
Delara	66071460	FDA UDI	Class II	Active
Basic 8, B4 / FO, CE	56739601	FDA UDI	Class II	Unknown
Basic 8, B3 / GU, CE	56739520	FDA UDI	Class II	Unknown
Mondial 6i, BL2 / L24, CE	66970677	FDA UDI	Class II	Active
Artic 8, C4 / 20 degree - 32 L, CE	66014150	FDA UDI	Class II	Active
Artic 8, A3 / 0 degree - 32 L, CE	66015122	FDA UDI	Class II	Active
Venus Diamond	66096871	FDA UDI	Class II	Active
Basic 6, B4 / U02, CE	56739265	FDA UDI	Class II	Unknown
Paladon 65, 500 ml	64707674	FDA UDI	Class II	Active
Mondial 8i, A2 / 37 U, CE	66973798	FDA UDI	Class II	Active
Artic digital 8, B2 / 10 degrees-32 UD, CE	66080698	FDA UDI	Class II	Active
Premium 6, C4 / O2, CE	66006887	FDA UDI	Class II	Unknown
HeraCeram Opalschneide OS4, 100g	66003467	FDA UDI	Class II	Unknown
Premium 6, B1 / R2, CE	66007048	FDA UDI	Class II	Unknown
Charisma	66000093	FDA UDI	Class II	Active
Mondial 6, C1 / O525, CE	66017109	FDA UDI	Class II	Active
Premium 8, B4 / M, CE	66007227	FDA UDI	Class II	Unknown
Premium 6, B2 / R4, CE	66007065	FDA UDI	Class II	Unknown
Mondial 8i, B3 / 37 U, CE	66973846	FDA UDI	Class II	Active
Premium 8, C1 / ML, CE	66007244	FDA UDI	Class II	Unknown
Charisma ABC	66064778	FDA UDI	Class II	Active
SMALL ASSORT Mondial 6/8 A1/A2 US	66046011	FDA UDI	Class II	Unknown
Mondial 6, C1 / L384, CE	66017121	FDA UDI	Class II	Active
Artic	66080499	FDA UDI	Class II	Active
Artic 8, C3 / 10 degree - 30 U, CE	66015213	FDA UDI	Class II	Active
Artic 8, D2 / 20 degree - 34 U, CE	66014160	FDA UDI	Class II	Active
Premium 6, B3 / S6, CE	66007130	FDA UDI	Class II	Unknown
Delara	66071419	FDA UDI	Class II	Active
Mondial 8, C2 / 29L, CE	66017392	FDA UDI	Class II	Active
Artic digital 6, C3 / T20D, CE	66080508	FDA UDI	Class II	Active
VENUS DIAMOND SYRINGE REFILL 1x4G A2	66035472	FDA UDI	Class II	Active
Mondial 6 DS, B1 / L315, CE	66985777	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