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Kulzer, Inc.

US

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 82 of 123
DeviceModel / ReferenceRegistriesClassStatus
Delara 66071638
FDA UDI
Class IIActive
Delara 66071501
FDA UDI
Class IIActive
Artic 6, A3.5 / T 15, CE 66014897
FDA UDI
Class IIActive
ST Artic 8, CE 66030383
FDA UDI
Class IIActive
Premium 6, C4 / R2, CE 66007055
FDA UDI
Class IIUnknown
Premium 6, B4 / O6, CE 66007035
FDA UDI
Class IIUnknown
Artic 66080583
FDA UDI
Class IIActive
Delara 66071356
FDA UDI
Class IIActive
Delara 66071552
FDA UDI
Class IIActive
Premium 6, C1 / R2, CE 66007052
FDA UDI
Class IIUnknown
Mondial 8, B2 / 30 U, CE 66802142
FDA UDI
Class IIActive
Artic 66080712
FDA UDI
Class IIActive
Premium 8, BL3 / L, CE 66803006
FDA UDI
Class IIUnknown
Basic 8, B3 / FO, CE 56739600
FDA UDI
Class IIUnknown
Artic 8, C2 / 20 degree - 34 U, CE 66012965
FDA UDI
Class IIActive
Mondial 8, A4 / 32 U, CE 66802132
FDA UDI
Class IIActive
Signum matrix 66019680
FDA UDI
Class IIActive
Delara 66071395
FDA UDI
Class IIActive
Artic digital 6, C1 / TO05D, CE 66080467
FDA UDI
Class IIActive
Mondial 6i, C4 / T4, CE 66970771
FDA UDI
Class IIActive
Mondial 6, A3 / T495, CE 66975533
FDA UDI
Class IIActive
Mondial 8, C1 / 37L, CE 66017390
FDA UDI
Class IIActive
Mondial 8i, D2 / 37 U, CE 66973910
FDA UDI
Class IIActive
Artic 8, D4 / 30 degree - 34 L, CE 66037090
FDA UDI
Class IIActive
Delara 66071606
FDA UDI
Class IIActive
Delara 66071282
FDA UDI
Class IIActive
Signum matrix 66019702
FDA UDI
Class IIActive
Artic 8, A2 / 30 degree - 34 L, CE 66037006
FDA UDI
Class IIActive
Mondial 8, A4 / 37L, CE 66017340
FDA UDI
Class IIActive
Mondial 8, A3 / 37 U, CE 66017319
FDA UDI
Class IIActive
Artic 6, D4 / L 30, CE 66014099
FDA UDI
Class IIActive
Delara 66071660
FDA UDI
Class IIActive
Artic digital 8, A2 / 20 degrees-30LD, CE 66080651
FDA UDI
Class IIActive
Mondial 6, C2 / O525, CE 66017137
FDA UDI
Class IIActive
Mondial 6, D2 / R455, CE 66017210
FDA UDI
Class IIActive
Mondial 6i, A3 / L16, CE 66970518
FDA UDI
Class IIActive
Premium 6, C3 / S6, CE 66007134
FDA UDI
Class IIUnknown
Basic 6, D2 / U04, CE 56739302
FDA UDI
Class IIUnknown
Premium 8, A4 / S, CE 66007255
FDA UDI
Class IIUnknown
Mondial 6i, C1 / O2, CE 66970707
FDA UDI
Class IIActive
Artic digital 8, BL3 / 10 degrees-30LD, CE 66080797
FDA UDI
Class IIActive
Artic 8, A1 / 10 degree - 30 U, CE 66015103
FDA UDI
Class IIActive
Artic 6, C3 / O 20, CE 66014050
FDA UDI
Class IIActive
Mondial 6i, C1 / T2, CE 66970704
FDA UDI
Class IIActive
Mondial 8i, B2 / XSL, CE 66970903
FDA UDI
Class IIActive
Mondial 6i, C2 / L20, CE 66970741
FDA UDI
Class IIActive
Artic 6, C3 / TO 10, CE 66015028
FDA UDI
Class IIActive
Artic 8, B3 / 20 degree - 32 U, CE 66014137
FDA UDI
Class IIActive
Premium 6, C4 / T2, CE 66007151
FDA UDI
Class IIUnknown
Artic 6, B4 / L 40, CE 66014102
FDA UDI
Class IIActive

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Authorised Representatives

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Importers

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Authorities

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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