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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 18 of 123

Device	Model / Reference	Registries	Class	Status
Basic 6, D3 / A12, CE	56739047	FDA UDI	Class II	Unknown
Mondial 6i, B4 / T6, CE	66970640	FDA UDI	Class II	Active
Mondial 6i, A2 / L24, CE	66970501	FDA UDI	Class II	Active
Mondial 6, C1 / O457, CE	66017107	FDA UDI	Class II	Active
Artic 6, A3 / S 10, CE	66012814	FDA UDI	Class II	Active
Artic 6, B2 / S 30, CE	66012831	FDA UDI	Class II	Active
Premium 6, B1 / R6, CE	66007080	FDA UDI	Class II	Unknown
Mondial 6i, C2 / L18, CE	66970739	FDA UDI	Class II	Active
Artic 6, C4 / T 40, CE	66014033	FDA UDI	Class II	Active
Mondial 6i, B4 / L12, CE	66970648	FDA UDI	Class II	Active
Premium 6, D2 / S4, CE	66007120	FDA UDI	Class II	Unknown
Artic digital 8, B4 / 20 degree-34 UD, CE	66983237	FDA UDI	Class II	Active
Mondial 8i, B4 / LL, CE	66970925	FDA UDI	Class II	Active
Artic digital 6, D2 / R30D, CE	66983156	FDA UDI	Class II	Active
VENUS Diamond FLOW	66100271	FDA UDI	Class II	Active
Mondial 6, BL3 / T495, CE	66975597	FDA UDI	Class II	Active
Basic 6, C1 / P21, CE	56739202	FDA UDI	Class II	Unknown
Mondial 8i, BL2 / 33L, CE	66973859	FDA UDI	Class II	Active
Venus Pearl	66096867	FDA UDI	Class II	Active
Basic 8, B3 / CO, CE	56739440	FDA UDI	Class II	Unknown
Mondial 6i DS, B1 / L12, CE	66986343	FDA UDI	Class II	Unknown
Artic 6, D2 / S 40, CE	66013998	FDA UDI	Class II	Active
Artic 6, A3 / S 05, CE	66014879	FDA UDI	Class II	Active
Artic 6, C4 / S 30, CE	66013988	FDA UDI	Class II	Active
Mondial 6, C3 / O457, CE	66017163	FDA UDI	Class II	Active
Basic 6, A2 / P21, CE	56739194	FDA UDI	Class II	Unknown
Basic 6, A3.5 / U04, CE	56739292	FDA UDI	Class II	Unknown
Artic digital 8, C2 / 10 degrees-32LD, CE	66080739	FDA UDI	Class II	Active
Artic digital 8, A3 / 10 degrees-32 UD, CE	66080658	FDA UDI	Class II	Active
Signum	64714211	FDA UDI	Class II	Active
Mondial 6, BL2 / L362, CE	66801041	FDA UDI	Class II	Active
Artic	66080378	FDA UDI	Class II	Active
Artic	66080395	FDA UDI	Class II	Active
Mondial 6, C2 / S550, CE	66975609	FDA UDI	Class II	Active
HeraCeram Pastenopaker PO B1, 2ml	66003349	FDA UDI	Class II	Unknown
Mondial 6i, B3 / R8, CE	66970615	FDA UDI	Class II	Active
Mondial 8i, A4 / XS, CE	66970886	FDA UDI	Class II	Active
Mondial 6, A2 / R520, CE	66975518	FDA UDI	Class II	Active
Mondial 6 DS, A2 / T405, CE	66985623	FDA UDI	Class II	Unknown
Mondial 8i, B2 / 35 U, CE	66973836	FDA UDI	Class II	Active
Mondial 6i DS, A2 / L14, CE	66986256	FDA UDI	Class II	Unknown
Mondial 8i, B1 / 33 U, CE	66973826	FDA UDI	Class II	Active
Mondial 6, C3 / S502, CE	66975616	FDA UDI	Class II	Active
Mondial 6, D2 / S550, CE	66975633	FDA UDI	Class II	Active
Mondial 6 DS, A3 / R455, CE	66985650	FDA UDI	Class II	Unknown
Artic 6, A1 / O 10, CE	66012868	FDA UDI	Class II	Active
Artic 6, A1 / L 25, CE	66014856	FDA UDI	Class II	Active
Mondial 6 DS, A3.5 / T495, CE	66985703	FDA UDI	Class II	Unknown
Mondial 6 DS, A2 / S445, CE	66985618	FDA UDI	Class II	Unknown
Premium 6, BL3 / O4, CE	66802955	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