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Demant Operations Poland Sp. z o.o.: FDA-registered device maker in Mierzyn Zachodniopomorskie, Poland, 1 510(k) clearance

Name: Demant Operations Poland Sp. z o.o. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Demant Operations Poland Sp. z o.o. is registered with the FDA (registration 3009307953) in Mierzyn Zachodniopomorskie, Poland. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 18, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009307953
Address: ul. Lubieszynska 59, Mierzyn Zachodniopomorskie, Poland, 72-006
Owner or operator: DEMANT A/S (8010048)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: January 9, 1995
Registered through: 2026
Brand names listed: AGXO A, AGXO B, AGXO E, AGXO F, AGXO G, AGXO G S, Abutment inserter, machine, Abutment, 12mm and more

Devices it lists

Device	Product code	Class	Role	Source
Active Implantable Bone Conduction Hearing System	PFO	2	Contract manufacturer	accessdata.fda.gov
Face Plate Hearing Aid	LRB	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Air-Conduction, Prescription	ESD	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Bone Conduction	LXB	2	Contract manufacturer	accessdata.fda.gov
Hearing Aid, Bone Conduction, Implanted	MAH	2	Contract manufacturer	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Masker, Tinnitus	KLW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 18, 2014	K133308	TINNITUS SOUNDSUPPORT	KLW	Substantially Equivalent	Oticon A/S	accessdata.fda.gov

Compare with other makers

Updated March 18, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.