Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010375018

FEI Number

3010375018

Entity Name

ABNOX AG

City/State/Country

Cham Zug, CH

Establishment Address

Langackerstrasse 25, Cham Zug 6330, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ABNOX AG (Owner Number: 10044550)

Owner / Operator Contact Address

Langackerstrasse 25, Cham, CH-ZG 6330, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-06-26
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2013-06-26
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-06-26
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-06-26

Official Correspondent

Benjamin Iseli

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

ABNOX AG

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

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9616696	STRYKER IRELAND LTD., INSTRUMENTS DIVISION	CARRIGTWOHILL, CO.CORK Munster, IE
1824199	WARSAW ORTHOPEDIC, INC.	WARSAW, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010375018. Last updated year: 2026. Please use registration number 3010375018 when referencing this establishment in official correspondence.