Eberle GmbH & Co. KG

FDA Device Registration & Listing · WURMBERG Baden-Wurttemberg, DE · Registration 3005820796

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005820796
FEI Number
3005820796
Entity Name
Eberle GmbH & Co. KG
City/State/Country
WURMBERG Baden-Wurttemberg, DE
Establishment Address
GLASBRONNENSTRASSE 6, WURMBERG Baden-Wurttemberg D-75449, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
EFS-EBERLE FEINWERKTECHN. SYSTEME GMBH & CO. KG (Owner Number: 9086231)
Owner / Operator Contact Address
GLASBRONNENSTRASSE 6, --, WURMBERG, DE-NOTA D-75449, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OTOMAG BONE CONDUCATION HEARING SYSTEM ENT/NEURO/OMF System and Accessory (41305RN) ENT/NEURO/OMF System and Accessory (41305D) ENT/NEURO/OMF System and Accessory (41301KSA) ENT/NEURO/OMF System and Accessory (41304KKF) ENT/NEURO/OMF System and Accessory (41301GN) ENT/NEURO/OMF System and Accessory (41305DW) ENT/NEURO/OMF System and Accessory (41201KK) ENT/NEURO/OMF System and Accessory (41304KKB) ENT/NEURO/OMF System and Accessory (41303KNF) ENT/NEURO/OMF System and Accessory (41301LN) ENT/NEURO/OMF System and Accessory (41304W) ENT/NEURO/OMF System and Accessory (41303GNF) ENT/NEURO/OMF System and Accessory (41303KNB) ENT/NEURO/OMF System and Accessory (41201SN) ENT/NEURO/OMF System and Accessory (41303KKFA) ENT/NEURO/OMF System and Accessory (41201GN) ENT/NEURO/OMF System and Accessory (41201LSA) ENT/NEURO/OMF System and Accessory (41303KKF) ENT/NEURO/OMF System and Accessory (41301KKSA) ENT/NEURO/OMF System and Accessory (41303KKB) ENT/NEURO/OMF System and Accessory (41201KN) ENT/NEURO/OMF System and Accessory (41301SN) ENT/NEURO/OMF System and Accessory (41303KKBA) ENT/NEURO/OMF System and Accessory (41303GNB) ENT/NEURO/OMF System and Accessory (41302KN) ENT/NEURO/OMF System and Accessory (41305DN) ENT/NEURO/OMF System and Accessory (41301LX) ENT/NEURO/OMF System and Accessory (41304KKFA) ENT/NEURO/OMF System and Accessory (41201LN) ENT/NEURO/OMF System and Accessory (41201KKSA) ENT/NEURO/OMF System and Accessory (41301KN) ENT/NEURO/OMF System and Accessory (41301LSA) ENT/NEURO/OMF System and Accessory (41301KK) ENT/NEURO/OMF System and Accessory (41201KKSB) ENT/NEURO/OMF System and Accessory (41201KSA) ENT/NEURO/OMF System and Accessory (40711040) ENT/NEURO/OMF System and Accessory (41303WN) ENT/NEURO/OMF System and Accessory (41303DT) ENT/NEURO/OMF System and Accessory (41304KKBA) ENT/NEURO/OMF System and Accessory (41301LXA) ENT/NEURO/OMF System and Accessory (41301KKSB) Cleaning Brushes and kits (41200RA) Cleaning Brushes and kits (41250RA) KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES Tamberger-Sachase Intranasal Drill (41335DT) Tamberger-Sachase Intranasal Drill (41335DS) Tamberger-Sachase Intranasal Drill (41335W) Tamberger-Sachase Intranasal Drill (41335DW) Tamberger-Sachase Intranasal Drill (41335RN) EBERLE SHAVER SYSTEM Eberle Shaver system Accessories HEMPFLING Dilation Set (28140W)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2015-11-05
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2019-10-18
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2019-10-18
EQL Laryngostroboscope Ear, Nose, Throat Class 1 874.4750 2019-10-18
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2019-10-08
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2019-10-15
HRX Arthroscope Orthopedic Class 2 888.1100 2006-06-15
HRX Arthroscope Orthopedic Class 2 888.1100 2012-12-19
HRX Arthroscope Orthopedic Class 2 888.1100 2019-10-18

Official Correspondent

No official correspondent registered.

US Agent Details

GERALDGOIGITZER Goigitzer Business: INNOVATIVE ENDOSCOPY COMPONENTS, LLC. Email: mike@endoscopy.md Phone: (954) 2178780

Related Public Records

Same Entity

EFS-EBERLE FEINWERKTECHN. SYSTEME GMBH & CO. KG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964548 Linvatec Corp. APEX UNIVERSAL DRIVE SYSTEM 1997-01-17
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005820796. Last updated year: 2026. Please use registration number 3005820796 when referencing this establishment in official correspondence.
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