Data / Medical devices / Germany / Eberle GmbH & Co. KG

Eberle GmbH & Co. KG: FDA-registered device maker in WURMBERG Baden-Wurttemberg, Germany, 3 510(k) clearances

Name: Eberle GmbH & Co. KG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Eberle GmbH & Co. KG is registered with the FDA (registration 3005820796) in WURMBERG Baden-Wurttemberg, Germany. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 1, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005820796
Address: Glasbronnenstrasse 6, WURMBERG Baden-Wurttemberg, Germany, D-75449
Owner or operator: EFS-EBERLE FEINWERKTECHN. SYSTEME GMBH & CO. KG (9086231)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: June 15, 2006
Registered through: 2026
Brand names listed: 091234-01, 091234-10, 091244-01, 091244-10, 27056LM, Cleaning Brushes and kits (41200RA), Cleaning Brushes and kits (41250RA), EBERLE SHAVER SYSTEM and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Contract manufacturer	accessdata.fda.gov
Arthroscope	HRX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bur, Ear, Nose And Throat	EQJ	1	Contract manufacturer	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Contract manufacturer	accessdata.fda.gov
Hearing Aid, Bone Conduction	LXB	2	Contract manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Laryngostroboscope	EQL	1	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer, 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
September 1, 2026	K260884	UNIDRIVE Select System	GCJ	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
September 29, 2010	K092977	EBERLE SHAVER SYSTEM ACCESSORIES	HRX	Substantially Equivalent	Efs Eberle Feinwerktechnische Systeme	accessdata.fda.gov
September 1, 2006	K061134	EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES	HRX	Substantially Equivalent	Efs Eberle Feinwerktechnische Systeme	accessdata.fda.gov

Compare with other makers

Updated September 1, 2026. 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.