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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 84 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071176	FDA UDI	Class II	Active
Mondial 6, A3 / T450, CE	66016906	FDA UDI	Class II	Active
Premium 6, D4 / L18, CE	66006960	FDA UDI	Class II	Unknown
Artic digital 8, A3.5 / 10 degrees-30 UD, CE	66080666	FDA UDI	Class II	Active
Delara	66071594	FDA UDI	Class II	Active
Venus Pearl	66081841	FDA UDI	Class II	Unknown
Cara	66081716	FDA UDI	Class II	Active
Artic digital 8, A4 / 20 degrees-30 UD, CE	66080680	FDA UDI	Class II	Active
VENUS FLOW SYR 1 x 1, 8G - A4	66014567	FDA UDI	Class II	Active
Mondial 6, D3 / O510, CE	66017248	FDA UDI	Class II	Active
Premium 8, A3 / XS, CE	66007285	FDA UDI	Class II	Unknown
Mondial 8, BL3 / 37L, CE	66801133	FDA UDI	Class II	Active
Dima	66077051	FDA UDI	Class II	Active
Mondial 6, C3 / L382, CE	66017176	FDA UDI	Class II	Active
Artic 8, B2 / 20 degree - 34 U, CE	66012964	FDA UDI	Class II	Active
Premium 6, C1 / L12, CE	66006906	FDA UDI	Class II	Unknown
Mondial 6, D4 / O444, CE	66017274	FDA UDI	Class II	Active
Provil Novo Med. F Cd2 1x(2x50ml)	66008291	FDA UDI	Class II	Unknown
Premium 6, B4 / T2, CE	66007147	FDA UDI	Class II	Unknown
Durafill VS	66000014	FDA UDI	Class II	Active
Artic digital 8, A3.5 / 20 degree-34LD, CE	66983208	FDA UDI	Class II	Active
Artic digital 6, A4 / TO40D, CE	66080360	FDA UDI	Class II	Active
Artic 6, B2 / T 30, CE	66012859	FDA UDI	Class II	Active
Artic digital 6, A3 / TO40D, CE	66080316	FDA UDI	Class II	Active
Delara	66071380	FDA UDI	Class II	Active
Artic 6, BL3 / L 30, CE	66970417	FDA UDI	Class II	Active
Artic 8, C1 / 0 degree - 30 L, CE	66015190	FDA UDI	Class II	Active
Basic 8, C2 / DU, CE	56739491	FDA UDI	Class II	Unknown
Dynamix Mixing Tips (1 X 50)	40004353	FDA UDI	Class I	Active
Mondial 8, A3 / 31 U, CE	66017313	FDA UDI	Class II	Active
Basic 8, A1 / FU, CE	56739609	FDA UDI	Class II	Unknown
Artic 8, B1 / 30 degree - 34 L, CE	66037030	FDA UDI	Class II	Active
Basic 8, D3 / HU, CE	56739559	FDA UDI	Class II	Unknown
Mondial 6i, D4 / L22, CE	66970852	FDA UDI	Class II	Active
Artic 8, A2 / 10 degree - 32 L, CE	66015116	FDA UDI	Class II	Active
Mondial 6i, C3 / S2, CE	66970754	FDA UDI	Class II	Active
Artic 8, C1 / 30 degree - 30 L, CE	66037050	FDA UDI	Class II	Active
Mondial 6 DS, B1 / T405, CE	66985767	FDA UDI	Class II	Unknown
Artic 8, B3 / 0 degree - 30 L, CE	66015170	FDA UDI	Class II	Active
Premium 8, D3 / XSL, CE	66007313	FDA UDI	Class II	Unknown
Artic 8, A3 / 10 degree - 32 L, CE	66015126	FDA UDI	Class II	Active
HeraCeram Opalschneide OS2, 20g	66003462	FDA UDI	Class II	Unknown
Artic 8, C1 / 20 degree - 34 U, CE	66014157	FDA UDI	Class II	Active
Mondial 8 DS, A3 / 31 U, CE	66986637	FDA UDI	Class II	Unknown
Mondial 8, C3 / 29 U, CE	66017401	FDA UDI	Class II	Active
Delara	66071202	FDA UDI	Class II	Active
Flow Line Syr 2 X 1 Ml - B2	66000345	FDA UDI	Class II	Unknown
Artic digital 8, C4 / 10 degrees-32 UD, CE	66080758	FDA UDI	Class II	Active
Artic digital 8, A4 / 10 degrees-30LD, CE	66080677	FDA UDI	Class II	Active
Basic 8, C1 / CU, CE	56739458	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