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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 97 of 123

Device	Model / Reference	Registries	Class	Status
Artic 6, C3 / O 10, CE	66014041	FDA UDI	Class II	Active
Mondial 6, D3 / T495, CE	66975645	FDA UDI	Class II	Active
Basic 6, B1 / A11, CE	56739022	FDA UDI	Class II	Unknown
Xantasil	66052101	FDA UDI	Class II	Active
Mondial 8 DS, A1 / 35 U, CE	66986621	FDA UDI	Class II	Unknown
Artic 6, B2 / L 55, CE	66014954	FDA UDI	Class II	Active
Mondial 6, A2 / T405, CE	66016876	FDA UDI	Class II	Active
Provil Novo Mono 1x280 Ml	66046458	FDA UDI	Class II	Unknown
PalaXpress ultra, pink veined, 100g	66034269	FDA UDI	Class II	Unknown
Artic 6, A3.5 / TO 30, CE	66012885	FDA UDI	Class II	Active
Mondial 8, D3 / 35L, CE	66017438	FDA UDI	Class II	Active
Artic 6, B1 / S 05, CE	66014927	FDA UDI	Class II	Active
Venus Pearl	66048176	FDA UDI	Class II	Active
Artic	66080593	FDA UDI	Class II	Active
Mondial 8 DS, A1 / 33 U, CE	66986619	FDA UDI	Class II	Unknown
Artic	66080549	FDA UDI	Class II	Active
Delara	66071477	FDA UDI	Class II	Active
Venus Pearl	66096879	FDA UDI	Class II	Active
Delara	66071595	FDA UDI	Class II	Active
Mondial 8i, BL3 / XSL, CE	66970935	FDA UDI	Class II	Active
Artic digital 6, B3 / L20D, CE	66983085	FDA UDI	Class II	Active
Mondial 6i DS, A2 / L12, CE	66986255	FDA UDI	Class II	Unknown
Mondial 8i, A3.5 / LL, CE	66970885	FDA UDI	Class II	Active
Artic 8, D4 / 0 degree - 30 U, CE	66015249	FDA UDI	Class II	Active
Trial kit Mondial 6/8 - USA	66031355	FDA UDI	Class II	Active
Flexitime Bite Bulk Pack 50x50ml	66067666	FDA UDI	Class II	Active
Premium 6, D2 / R4, CE	66007072	FDA UDI	Class II	Unknown
Palapress Vario	64707893	FDA UDI	Class II	Active
Artic 6, C4 / R 30, CE	66015037	FDA UDI	Class II	Active
Premium 6, C3 / T2, CE	66007150	FDA UDI	Class II	Unknown
Basic 6, C1 / L06, CE	56739154	FDA UDI	Class II	Unknown
Mondial 6, A4 / O444, CE	66016966	FDA UDI	Class II	Active
Mondial 8i, BL2 / 35L, CE	66973861	FDA UDI	Class II	Active
Delara	66071489	FDA UDI	Class II	Active
Artic 6, C1 / L 55, CE	66015002	FDA UDI	Class II	Active
Mondial 6 DS, A1 / T477, CE	66985594	FDA UDI	Class II	Unknown
Artic 6, A3.5 / TO 05, CE	66014899	FDA UDI	Class II	Active
Venus Pearl	66048178	FDA UDI	Class II	Active
Delara	66071569	FDA UDI	Class II	Active
Artic 6, B4 / T 15, CE	66014977	FDA UDI	Class II	Active
Artic 6, A3.5 / S 35, CE	66014896	FDA UDI	Class II	Active
Basic 6, D4 / L03, CE	56739112	FDA UDI	Class II	Unknown
Delara	66071593	FDA UDI	Class II	Active
Artic	66080584	FDA UDI	Class II	Active
Venus Pearl	66048184	FDA UDI	Class II	Active
Mondial 8i, C2 / 31L, CE	66973881	FDA UDI	Class II	Active
Venus Pearl	66048194	FDA UDI	Class II	Active
Venus Temp 2 Cartridge Refill A3.5	66049183	FDA UDI	Class II	Unknown
Premium 6, D3 / L22, CE	66006992	FDA UDI	Class II	Unknown
Mondial 6i, C4 / S8, CE	66970779	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