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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 102 of 123
DeviceModel / ReferenceRegistriesClassStatus
Venus Diamond 66035484
FDA UDI
Class IIActive
Delara 66071465
FDA UDI
Class IIActive
Basic 6, D4 / L04, CE 56739128
FDA UDI
Class IIUnknown
Artic digital 6, C1 / S30D, CE 66983114
FDA UDI
Class IIActive
Mondial 6i, C1 / L24, CE 66970721
FDA UDI
Class IIActive
Mondial 8i, B1 / L, CE 66970900
FDA UDI
Class IIActive
Mondial 8i, BL3 / SL, CE 66970937
FDA UDI
Class IIActive
Mondial 6i, BL2 / S4, CE 66970667
FDA UDI
Class IIActive
Signum composite 66020028
FDA UDI
Class IIActive
Delara 66071686
FDA UDI
Class IIActive
Delara 66071430
FDA UDI
Class IIActive
Venus Pearl 66081836
FDA UDI
Class IIActive
Artic 66080775
FDA UDI
Class IIActive
Mondial 8i, A4 / 37L, CE 66973823
FDA UDI
Class IIActive
Mondial 6, BL2 / R410, CE 66801024
FDA UDI
Class IIActive
Delara 66078136
FDA UDI
Class IIActive
Mondial 6, BL2 / L315, CE 66801038
FDA UDI
Class IIActive
Artic 66080705
FDA UDI
Class IIActive
Artic 66080543
FDA UDI
Class IIActive
Mondial 8, A1 / 37L, CE 66017300
FDA UDI
Class IIActive
Basic 6, D2 / U02, CE 56739270
FDA UDI
Class IIUnknown
Artic 66080590
FDA UDI
Class IIActive
Artic 6, C1 / L 20, CE 66014085
FDA UDI
Class IIActive
Artic 66080703
FDA UDI
Class IIActive
Basic 6, C1 / P22, CE 56739218
FDA UDI
Class IIUnknown
Charisma 66000116
FDA UDI
Class IIActive
Basic 6, A2 / L01, CE 56739066
FDA UDI
Class IIUnknown
Artic digital 6, B2 / R20D, CE 66983067
FDA UDI
Class IIActive
Mondial 6i, C4 / T6, CE 66970772
FDA UDI
Class IIActive
Delara 66071317
FDA UDI
Class IIActive
Artic 6, B2 / R 30, CE 66014941
FDA UDI
Class IIActive
Basic 6, B4 / P22, CE 56739217
FDA UDI
Class IIUnknown
Mondial 6i, A3 / R4, CE 66970503
FDA UDI
Class IIActive
Delara 66071643
FDA UDI
Class IIActive
Artic 8, B2 / 20 degree - 32 U, CE 66012950
FDA UDI
Class IIActive
Mondial 6, BL1 / R410, CE 66800996
FDA UDI
Class IIUnknown
Premium 6, BL3 / S2, CE 66802957
FDA UDI
Class IIUnknown
Artic 8, B2 / 0 degree - 32 U, CE 66015161
FDA UDI
Class IIActive
Premium 6, A3 / R4, CE 66007061
FDA UDI
Class IIUnknown
Artic digital 6, C1 / R30D, CE 66983112
FDA UDI
Class IIActive
Mondial 6i, D2 / S6, CE 66970800
FDA UDI
Class IIActive
Artic 6, C3 / T 40, CE 66014032
FDA UDI
Class IIActive
Premium 6, BL2 / R6, CE 66802932
FDA UDI
Class IIUnknown
Artic 8, C1 / 20 degree - 30 L, CE 66014130
FDA UDI
Class IIActive
Basic 6, A3 / A12, CE 56739035
FDA UDI
Class IIUnknown
Flexitime 66099317
FDA UDI
Class IIActive
Delara 66071257
FDA UDI
Class IIActive
Mondial 6i, C2 / T6, CE 66970728
FDA UDI
Class IIActive
Mondial 6, B1 / T477, CE 66016992
FDA UDI
Class IIActive
Durafill VS 66000029
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

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Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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