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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 105 of 123

Device	Model / Reference	Registries	Class	Status
Delara	66071343	FDA UDI	Class II	Active
Delara	66071424	FDA UDI	Class II	Active
Delara	66071333	FDA UDI	Class II	Active
Mondial 6 DS, A2 / L384, CE	66985641	FDA UDI	Class II	Unknown
Artic digital 6, D4 / TO30D, CE	66080601	FDA UDI	Class II	Active
Mondial 8, BL1 / 37L, CE	66801113	FDA UDI	Class II	Unknown
Delara	66071306	FDA UDI	Class II	Active
Artic 8, C2 / 30 degree - 34 L, CE	66037060	FDA UDI	Class II	Active
Artic 8, A1 / 20 degree - 30 L, CE	66012938	FDA UDI	Class II	Active
Venus Pearl	66098276	FDA UDI	Class II	Active
Artic 8, B1 / 30 degree - 34 U, CE	66037029	FDA UDI	Class II	Active
Mondial 8, B1 / 33L, CE	66017346	FDA UDI	Class II	Active
Artic 6, B1 / TO 20, CE	66014933	FDA UDI	Class II	Active
Premium 6, A2 / L14, CE	66006914	FDA UDI	Class II	Unknown
Artic 6, B2 / L 05, CE	66014950	FDA UDI	Class II	Active
Premium 6, A3 / L16, CE	66006931	FDA UDI	Class II	Unknown
Mondial 6i, B3 / O2, CE	66970619	FDA UDI	Class II	Active
Artic digital 6, A3 / TO20D, CE	66983029	FDA UDI	Class II	Active
Mondial 6, D2 / R420, CE	66017208	FDA UDI	Class II	Active
Premium 6, C1 / T4, CE	66007164	FDA UDI	Class II	Unknown
Premium 8, C3 / S, CE	66007262	FDA UDI	Class II	Unknown
Mondial 8i, B3 / SL, CE	66970913	FDA UDI	Class II	Active
Mondial 8i DS, B1 / 33L, CE	66986884	FDA UDI	Class II	Unknown
Mondial 6i, C4 / L19, CE	66970784	FDA UDI	Class II	Active
Basic 6, A1 / U07, CE	56739337	FDA UDI	Class II	Unknown
Mondial 6, C3 / L384, CE	66017177	FDA UDI	Class II	Active
PalaXpress ultra, 80ml liquid	66034268	FDA UDI	Class II	Unknown
Basic 8, A3.5 / GU, CE	56739516	FDA UDI	Class II	Unknown
Basic 6, A2 / U04, CE	56739290	FDA UDI	Class II	Unknown
Artic 6, D3 / TO 05, CE	66015075	FDA UDI	Class II	Active
Artic 8, D2 / 20 degree - 36 U, CE	66015237	FDA UDI	Class II	Active
Artic 8, B1 / 10 degree - 32 L, CE	66015156	FDA UDI	Class II	Active
Basic 8, B4 / EO, CE	56739569	FDA UDI	Class II	Unknown
Artic 6, B2 / S 20, CE	66012824	FDA UDI	Class II	Active
Premium 6, D3 / R4, CE	66007073	FDA UDI	Class II	Unknown
Mondial 6, D2 / T465, CE	66017215	FDA UDI	Class II	Active
Artic 6, B2 / L 40, CE	66012922	FDA UDI	Class II	Active
Mondial 6i, C3 / R2, CE	66970744	FDA UDI	Class II	Active
Artic digital 6, B2 / TO20D, CE	66983073	FDA UDI	Class II	Active
Artic digital 6, D3 / T30D, CE	66983171	FDA UDI	Class II	Active
Artic 8, A3.5 / 30 degree - 30 U, CE	66037013	FDA UDI	Class II	Active
Delara	66071401	FDA UDI	Class II	Active
Mondial 6 DS, A1 / T435, CE	66985588	FDA UDI	Class II	Unknown
Basic 8, B4 / BU, CE	56739425	FDA UDI	Class II	Unknown
Basic 8, B1 / BU, CE	56739422	FDA UDI	Class II	Unknown
Flexitime Medium Flow 1x50ml Sample	66077378	FDA UDI	Class II	Active
Premium 8, A4 / XSL, CE	66007303	FDA UDI	Class II	Unknown
Premium 6, BL3 / O6, CE	66802956	FDA UDI	Class II	Unknown
Signum Opaque F	66020067	FDA UDI	Class II	Active
Artic digital 6, A1 / R40D, CE	66983003	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