Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003847101

FEI Number

3003847101

Entity Name

ELOS MEDTECH TIMMERSDALA AB

City/State/Country

TIMMERSDALA Vastra Gotaland, SE

Establishment Address

BACKEDALSVAGEN, TIMMERSDALA Vastra Gotaland SE541 71, SE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ELOS MEDTECH AB (Owner Number: 9078344)

Owner / Operator Contact Address

BACKEDALSVAGEN, --, TIMMERSDALA, SE-O SE-541 71, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hearing aid, bone conduction, implanted COCHLEAR BAHA IMPLANT SYSTEM Titanium Fixation Screws Disposable Fixations Screws Reusable Fixations Screws OKTAGON Bone Level Implants Prosthesis, Nose, Internal Ratchet Wrench 45' UniAbutment Replica Implant Pick-up 3 Long Implant Guide Pin 4.5/5 L Implant Transfer 4.5/5 Short Implant Replica 3.5/4 Implant Transfer 3.5/4 Short Ball Abutment Replica Implant Guide Pin 3 Short Implant Replica 4.5/5 Impl Pick-up 3.5/4 Short Implant Pick-up 3.5/4 Long Impl Pick-up 3.5/4 NI Long 20' UniAbutment Replica Implant Transfer 3 Long Ball Wrench Implant Transfer 3.5/4 Long Implant Guide Pin 3.5/4 L Implant Guide Pin 4.5/5 S Impl Pick-up 3.5/4 NI Short Implant Guide Pin 3 Long Implant Pick-up 3 Short Impl Pick-up 4.5/5 NI Short Implant Replica 3 Multibase EV Lab Abutment Pin - 14 mm Implant Pick-up 4.5/5 Short Implant Guide Pin 3.5/4 S Implant Transfer 4.5/5 Long Multibase EV Lab Abutment Pin - 22 mm Multibase EV Lab Abutment Pin - 18 mm Implant Pick-up 4.5/5 Long Impl Pick-up 4.5/5 NI Long Hearing aid, bone conduction, implanted Bone Anchored Hearing Aid HII MICRO PIN/ROD CLAMP 1.5-2/3 HII MICRO ROD TO ROD CLAMP 3/3 HII MICRO ROD TO ROD CLAMP 5/3 OKTAGON Bone Level Tapered Implants OMEGA 2 SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2025-08-15
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2013-01-25
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-06-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-06-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-08-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-06-14
FZE	Prosthesis, Nose, Internal	General, Plastic Surgery	Class 2	878.3680	2025-08-15
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2025-08-15
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2025-08-15
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2013-01-25
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-12-30
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-08-15
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-12-30
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-06-14

Official Correspondent

Nils Kristensen

US Agent Details

JODIE GILMORE Business: ONYX MEDICAL CORPORATION Email: jodie.gilmore@elosmedtech.com Phone: (901) 3236699

Related Public Records

Same Entity

ELOS MEDTECH AB

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
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

Similar Registrations

Registration Number	Establishment Name	Location
9616024	COCHLEAR BONE ANCHORED SOLUTIONS AB	Molnlycke Vastra Gotaland, SE
3009307953	Demant Operations Poland Sp. z o.o.	Mierzyn Zachodniopomorskie, PL
3005900820	COCHLEAR AMERICAS	Lone Tree, CO, US
3007367732	Oticon Medical AB	Askim Vastra Gotaland, SE
3007051929	MEDICAL GROUP	SAINT-PRIEST Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003847101. Last updated year: 2026. Please use registration number 3003847101 when referencing this establishment in official correspondence.