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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 89 of 123

Device	Model / Reference	Registries	Class	Status
Mondial 6, C2 / O457, CE	66017135	FDA UDI	Class II	Active
Mondial 6, B2 / L398, CE	66017038	FDA UDI	Class II	Active
Mondial 6, C3 / R420, CE	66017152	FDA UDI	Class II	Active
Premium 8, A3.5 / SL, CE	66007270	FDA UDI	Class II	Unknown
Artic 8, A3.5 / 30 degree - 30 L, CE	66037014	FDA UDI	Class II	Active
Signum cre-active	66020054	FDA UDI	Class II	Active
Venus Pearl	66098267	FDA UDI	Class II	Active
Artic 6, B1 / O 20, CE	66012879	FDA UDI	Class II	Active
Mondial 8, C2 / 37L, CE	66017400	FDA UDI	Class II	Active
Mondial 6, A3 / L398, CE	66016926	FDA UDI	Class II	Active
Mondial 6i, D2 / T4, CE	66970793	FDA UDI	Class II	Active
Mondial 8, B4 / 33L, CE	66017376	FDA UDI	Class II	Active
Artic 8, D2 / 30 degree - 32 L, CE	66037076	FDA UDI	Class II	Active
Mondial 8, C2 / 31 U, CE	66017393	FDA UDI	Class II	Active
Mondial 6i, C3 / S8, CE	66970757	FDA UDI	Class II	Active
Mondial 8, B2 / 33L, CE	66017356	FDA UDI	Class II	Active
Mondial 6, C1 / S502, CE	66975600	FDA UDI	Class II	Active
Premium 6, B4 / R4, CE	66007067	FDA UDI	Class II	Unknown
Artic	66080263	FDA UDI	Class II	Active
Mondial 6, D4 / T477, CE	66017272	FDA UDI	Class II	Active
Delara	66071154	FDA UDI	Class II	Active
Basic 8, C4 / GU, CE	56739525	FDA UDI	Class II	Unknown
Mondial 8, BL1 / 31 U, CE	66801106	FDA UDI	Class II	Unknown
Mondial 6, D3 / L398, CE	66017262	FDA UDI	Class II	Active
Mondial 6, B2 / S453, CE	66017028	FDA UDI	Class II	Active
Flexitime Xtreme 2 Correct Flow 1x50ml	66050336	FDA UDI	Class II	Unknown
Artic 6, B3 / L 50, CE	66014110	FDA UDI	Class II	Active
Flow Line Syr 2 X 1 Ml - A2	66000343	FDA UDI	Class II	Unknown
Artic 8, A4 / 30 degree - 34 U, CE	66037023	FDA UDI	Class II	Active
Delara	66071141	FDA UDI	Class II	Active
Basic 6, D3 / P20, CE	56739191	FDA UDI	Class II	Unknown
Artic 6, A4 / TO 30, CE	66014055	FDA UDI	Class II	Active
Artic digital 6, D3 / R40D, CE	66983168	FDA UDI	Class II	Active
Artic digital 6, A3 / S30D, CE	66983026	FDA UDI	Class II	Active
Artic digital 8, A3.5 / 20 degree-32 UD, CE	66983205	FDA UDI	Class II	Active
Mondial 6i, D3 / R6, CE	66970812	FDA UDI	Class II	Active
Signum composite	66020010	FDA UDI	Class II	Active
Artic 8, D3 / 0 degree - 30 L, CE	66015240	FDA UDI	Class II	Active
Artic 8, A2 / 20 degree - 30 L, CE	66012939	FDA UDI	Class II	Active
Premium 6, BL3 / R4, CE	66802949	FDA UDI	Class II	Unknown
Mondial 6i, A1 / L22, CE	66970478	FDA UDI	Class II	Active
Basic 6, A4 / A13, CE	56739053	FDA UDI	Class II	Unknown
Artic digital 6, C4 / S40D, CE	66983148	FDA UDI	Class II	Active
Palapress Vario	64707891	FDA UDI	Class II	Active
Mondial 8i, BL3 / XS, CE	66970934	FDA UDI	Class II	Active
Artic digital 6, D3 / O30D, CE	66983165	FDA UDI	Class II	Active
Mondial 8, B2 / 31L, CE	66017354	FDA UDI	Class II	Active
Mondial 6, D4 / L398, CE	66017290	FDA UDI	Class II	Active
Mondial 6, B4 / T450, CE	66017074	FDA UDI	Class II	Active
Venus Diamond	66039022	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