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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 108 of 123

Device	Model / Reference	Registries	Class	Status
Artic digital 6, BL3 / TO05D, CE	66080621	FDA UDI	Class II	Active
Artic	66080702	FDA UDI	Class II	Active
Artic digital 8, A2 / 10 degrees-32 UD, CE	66080648	FDA UDI	Class II	Active
Delara	66071657	FDA UDI	Class II	Active
Delara	66071495	FDA UDI	Class II	Active
Artic digital 8, C2 / 20 degree-34 UD, CE	66983255	FDA UDI	Class II	Active
Artic digital 6, C3 / S40D, CE	66983137	FDA UDI	Class II	Active
Mondial 6, A1 / R520, CE	66975510	FDA UDI	Class II	Active
Artic	66080476	FDA UDI	Class II	Active
Artic digital 8, A2 / 20 degree-36LD, CE	66983198	FDA UDI	Class II	Active
Mondial 6, BL1 / S445, CE	66801002	FDA UDI	Class II	Unknown
Mondial 8, BL2 / 31L, CE	66801117	FDA UDI	Class II	Active
Basic 8, B1 / DU, CE	56739486	FDA UDI	Class II	Unknown
Basic 8, B4 / GU, CE	56739521	FDA UDI	Class II	Unknown
Mondial 8, C1 / 35L, CE	66017388	FDA UDI	Class II	Active
Mondial 6 DS, A3.5 / R483, CE	66985687	FDA UDI	Class II	Unknown
Basic 6, C3 / A11, CE	56739028	FDA UDI	Class II	Unknown
Basic 8, D2 / DU, CE	56739494	FDA UDI	Class II	Unknown
Premium 6, D2 / R6, CE	66007088	FDA UDI	Class II	Unknown
Basic 6, C1 / L03, CE	56739106	FDA UDI	Class II	Unknown
Artic	66080431	FDA UDI	Class II	Active
Delara	66071602	FDA UDI	Class II	Active
Mondial 6, D4 / L378, CE	66017287	FDA UDI	Class II	Active
Delara	66071348	FDA UDI	Class II	Active
Premium 6, B4 / L18, CE	66006953	FDA UDI	Class II	Unknown
Delara	66071206	FDA UDI	Class II	Active
Delara	66071223	FDA UDI	Class II	Active
Mondial 8i, A4 / ML, CE	66970891	FDA UDI	Class II	Active
Artic	66080275	FDA UDI	Class II	Active
Delara	66071608	FDA UDI	Class II	Active
Delara	66071527	FDA UDI	Class II	Active
Premium 6, C1 / L20, CE	66006970	FDA UDI	Class II	Unknown
Artic digital 6, C4 / TO30D, CE	66080535	FDA UDI	Class II	Active
Artic	66080454	FDA UDI	Class II	Active
Mondial 6, BL2 / O444, CE	66801020	FDA UDI	Class II	Active
Artic 6, A2 / S 35, CE	66014864	FDA UDI	Class II	Active
Mondial 6, B1 / L378, CE	66017007	FDA UDI	Class II	Active
Mondial 8, C1 / 37 U, CE	66017389	FDA UDI	Class II	Active
Artic 6, B3 / S 05, CE	66014959	FDA UDI	Class II	Active
Mondial 8, C1 / 30 U, CE	66802160	FDA UDI	Class II	Active
Mondial 6, C3 / T465, CE	66017159	FDA UDI	Class II	Active
Mondial 6, D4 / S451, CE	66975647	FDA UDI	Class II	Active
Mondial 6i DS, A2 / L18, CE	66986258	FDA UDI	Class II	Unknown
Mondial 6, BL2 / S451, CE	66975583	FDA UDI	Class II	Active
Artic digital 8, C3 / 20 degree-36 UD, CE	66983263	FDA UDI	Class II	Active
Basic 8, D4 / EU, CE	56739592	FDA UDI	Class II	Unknown
Mondial 8, A3.5 / 28L, CE	66802123	FDA UDI	Class II	Active
Delara	66071423	FDA UDI	Class II	Active
Venus Diamond	66039023	FDA UDI	Class II	Active
Basic 8, B2 / FO, CE	56739599	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