FDA Registration
Active
🇸🇪 Sweden
ELOS MEDTECH TIMMERSDALA AB
Reg #: 3003847101
·
FEI: 3003847101
·
Expires 2026
Products
9
Proprietary Names
54
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- ELOS MEDTECH TIMMERSDALA AB
- Registration Number
- 3003847101
- FEI Number
- 3003847101
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BACKEDALSVAGEN
- City
- TIMMERSDALA Vastra Gotaland
- Country
- SE
Owner / Operator
- Firm Name
- ELOS MEDTECH AB
- Operator Number
- 9078344
- Address
- BACKEDALSVAGEN, --
- City
- TIMMERSDALA
- State
- Vastra Gotaland
- Postal Code
- SE-541 71
- Country
- SE
- Correspondent
- Nils - Kristensen
US Agent
- Business Name
- ONYX MEDICAL CORPORATION
- Contact Name
- JODIE GILMORE
- Address
- 1800 North Shelby Oaks Drive
- City
- Memphis
- State
- TN
- ZIP
- 38134
- Country
- US
- [email protected]
- Phone
- 901 3236699
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Bone Conduction, Implanted | MAH | Class 2 | Ear, Nose, Throat | No | 2025-08-15 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2024-12-13 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2023-06-14 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2023-06-14 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2025-08-15 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2025-08-15 |
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2013-01-25 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-12-30 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-25 |
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
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
Dental Implant Oktagon
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
FirmFixTM 1
Leksell Vantage Cross-hairs
FirmFixTM 5
FirmFixTM Ruler
FirmFixTM 2
FirmFixTM 3
FirmFixTM 4
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)