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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 91 of 123

Device	Model / Reference	Registries	Class	Status
Artic 8, A3 / 20 degree - 34 L, CE	66012968	FDA UDI	Class II	Active
Mondial 6i, A1 / L19, CE	66970476	FDA UDI	Class II	Active
Delara	66071416	FDA UDI	Class II	Active
Delara	66071254	FDA UDI	Class II	Active
Mondial 6, A3 / R483, CE	66016903	FDA UDI	Class II	Active
Delara	66071352	FDA UDI	Class II	Active
Artic 6, D2 / T 15, CE	66015057	FDA UDI	Class II	Active
Mondial 6, B2 / T450, CE	66017018	FDA UDI	Class II	Active
Artic digital 6, B4 / T15D, CE	66080441	FDA UDI	Class II	Active
Delara	66071450	FDA UDI	Class II	Active
Artic digital 6, A3.5 / T35D, CE	66080333	FDA UDI	Class II	Active
Mondial 6i DS, B1 / L14, CE	66986344	FDA UDI	Class II	Unknown
Artic 6, A3 / T 40, CE	66012863	FDA UDI	Class II	Active
Mondial 8, BL1 / 30 U, CE	66802202	FDA UDI	Class II	Unknown
Mondial 6i, D3 / L12, CE	66970824	FDA UDI	Class II	Active
Artic 8, D2 / 20 degree - 34 L, CE	66014169	FDA UDI	Class II	Active
Artic digital 6, A4 / R20D, CE	66983045	FDA UDI	Class II	Active
Mondial 6i, B4 / L19, CE	66970652	FDA UDI	Class II	Active
Artic 6, BL3 / TO 10, CE	66970429	FDA UDI	Class II	Active
Basic 8, A1 / DU, CE	56739481	FDA UDI	Class II	Unknown
Premium 6, A1 / T2, CE	66007139	FDA UDI	Class II	Unknown
Mondial 6, C1 / L378, CE	66017119	FDA UDI	Class II	Active
Artic 6, D4 / L 05, CE	66015094	FDA UDI	Class II	Active
FLEXITIME DYNAMIX MONO REFILL(3X2X380ml)	66035993	FDA UDI	Class II	Unknown
Mondial 6, D3 / S445, CE	66017251	FDA UDI	Class II	Active
Delara	66071133	FDA UDI	Class II	Active
Ibond Universal Bottle Intro Kit	66061413	FDA UDI	Class II	Unknown
Artic 8, A1 / 10 degree - 32 U, CE	66015105	FDA UDI	Class II	Active
Signum Opaque F	66020073	FDA UDI	Class II	Active
Delara	66071488	FDA UDI	Class II	Active
Artic digital 8, A1 / 10 degrees-32 UD, CE	66080638	FDA UDI	Class II	Active
Artic digital 6, D2 / TO30D, CE	66080557	FDA UDI	Class II	Active
Flexitime Dynamix Putty & Flow Trial Kit	66041065	FDA UDI	Class II	Active
Mondial 8i, D2 / SL, CE	66970977	FDA UDI	Class II	Active
Mondial 8i DS, A1 / 31L, CE	66986802	FDA UDI	Class II	Unknown
Mondial 8 DS, A3 / 33L, CE	66986640	FDA UDI	Class II	Unknown
Mondial 6 DS, A3.5 / T405, CE	66985695	FDA UDI	Class II	Unknown
Basic 6, A1 / A12, CE	56739033	FDA UDI	Class II	Unknown
Artic 8, B2 / 30 degree - 32 U, CE	66037033	FDA UDI	Class II	Active
Delara	66071215	FDA UDI	Class II	Active
Mondial 6i, D2 / L18, CE	66970805	FDA UDI	Class II	Active
Artic digital 6, A2 / TO40D, CE	66080294	FDA UDI	Class II	Active
Delara	66071627	FDA UDI	Class II	Active
Delara	66071563	FDA UDI	Class II	Active
Mondial 6, C2 / L315, CE	66017141	FDA UDI	Class II	Active
Delara	66071661	FDA UDI	Class II	Active
Delara	66071259	FDA UDI	Class II	Active
Artic 8, D2 / 30 degree - 34 U, CE	66037077	FDA UDI	Class II	Active
Artic 6, B3 / TO 10, CE	66014964	FDA UDI	Class II	Active
Mondial 6, A3 / T477, CE	66016908	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