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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 98 of 123
DeviceModel / ReferenceRegistriesClassStatus
Artic 66080655
FDA UDI
Class IIActive
Artic digital 6, D3 / T20D, CE 66080574
FDA UDI
Class IIActive
Artic 66080753
FDA UDI
Class IIActive
VENUS DIAMOND PLT REFILL 1x10x0, 25G ODC 66046733
FDA UDI
Class IIActive
Mondial 6i, C3 / S6, CE 66970756
FDA UDI
Class IIActive
Mondial 8, BL2 / 33 U, CE 66801118
FDA UDI
Class IIActive
Artic 66080461
FDA UDI
Class IIActive
Basic 8, B4 / EU, CE 56739585
FDA UDI
Class IIUnknown
Artic 66080393
FDA UDI
Class IIActive
Mondial 8i, D2 / XSL, CE 66970975
FDA UDI
Class IIActive
Mondial 8i, D4 / M, CE 66970994
FDA UDI
Class IIActive
Basic 6, A1 / A10, CE 56739001
FDA UDI
Class IIUnknown
VENUS DIAMOND PLT REFILL 1x10x0, 25G OLC 66046731
FDA UDI
Class IIActive
Mondial 6 DS, A3.5 / L331, CE 66985706
FDA UDI
Class IIUnknown
Mondial 8i, A3 / 37L, CE 66973807
FDA UDI
Class IIActive
Mondial 8i, B1 / 31 U, CE 66973824
FDA UDI
Class IIActive
Artic 66080724
FDA UDI
Class IIActive
Mondial 6 DS, A2 / T515, CE 66985632
FDA UDI
Class IIUnknown
Mondial 6 DS, A3.5 / L384, CE 66985713
FDA UDI
Class IIUnknown
Mondial 6, C4 / S550, CE 66975625
FDA UDI
Class IIActive
Premium 8, C4 / SL, CE 66007279
FDA UDI
Class IIUnknown
Mondial 6 DS, A1 / L315, CE 66985597
FDA UDI
Class IIUnknown
Delara 66071614
FDA UDI
Class IIActive
Dima 66087418
FDA UDI
Class IIActive
Signum composite flow 66048943
FDA UDI
Class IIActive
Premium 6, A4 / L16, CE 66006933
FDA UDI
Class IIUnknown
Signum matrix 66019679
FDA UDI
Class IIActive
Artic 6, BL3 / L 05, CE 66970431
FDA UDI
Class IIActive
Venus Pearl 66081837
FDA UDI
Class IIActive
Artic 66080794
FDA UDI
Class IIActive
Mondial 8 DS, A2 / 31L, CE 66986628
FDA UDI
Class IIUnknown
VENUS DIAMOND SYRINGE REFILL 1x4G B1 66035478
FDA UDI
Class IIActive
Basic 8, A4 / EO, CE 56739565
FDA UDI
Class IIUnknown
Artic 66080516
FDA UDI
Class IIActive
Delara 66071542
FDA UDI
Class IIActive
Venus Pearl Plt Masters Kit 66048214
FDA UDI
Class IIActive
Artic 66080568
FDA UDI
Class IIActive
Basic 8, A3 / EU, CE 56739579
FDA UDI
Class IIUnknown
Charisma 66000090
FDA UDI
Class IIActive
Artic digital 8, C2 / 20 degree-34LD, CE 66983256
FDA UDI
Class IIActive
Basic 8, D4 / EO, CE 56739576
FDA UDI
Class IIUnknown
Artic 66080342
FDA UDI
Class IIActive
Mondial 6i, C2 / S8, CE 66970735
FDA UDI
Class IIActive
Premium 6, A1 / R4, CE 66007059
FDA UDI
Class IIUnknown
Artic 6, B2 / T 10, CE 66012845
FDA UDI
Class IIActive
Delara 66071324
FDA UDI
Class IIActive
Artic digital 8, B2 / 20 degree-34LD, CE 66983226
FDA UDI
Class IIActive
Mondial 6i, C3 / O4, CE 66970752
FDA UDI
Class IIActive
Artic 8, A3.5 / 30 degree - 34 U, CE 66037017
FDA UDI
Class IIActive
Premium 6, A3 / T4, CE 66007157
FDA UDI
Class IIUnknown

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