FDA Device Entity Profile: Kulzer, LLC

Known Identifiers & Locations

FEI Numbers 1821514, 3002807166, 3005665377, 3006610834, 3011203516

Owner Operator Numbers 9056636

Locations Covered HANAU Hesse, DE; SOUTH BEND, IN, US; Sacalaz-Judet Timis, RO; WASSERBURG Bavaria, DE; WEHRHEIM Hesse, DE

Registered Establishments (5)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1821514	KULZER, LLC	SOUTH BEND, IN, US	Repack or Relabel Medical Device	View Details
3005665377	KULZER GMBH	HANAU Hesse, DE	Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device	View Details
3006610834	KULZER GMBH	WASSERBURG Bavaria, DE	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3011203516	Kulzer SRL	Sacalaz-Judet Timis, RO	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
9610902	KULZER GMBH	WEHRHEIM Hesse, DE	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K254063	iCEM Universal Plus	2025-12-19	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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