FDA Registration
Active
🇩🇰 Denmark
Achieve
Reg #: 3005650109
·
FEI: 3005650109
·
Expires 2025
Products
1
Proprietary Names
56
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- GN Hearing A/S
- Registration Number
- 3005650109
- FEI Number
- 3005650109
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LAUTRUPBJERG 7
- City
- BALLERUP Hovedstaden
- Country
- DK
Owner / Operator
- Firm Name
- GN Hearing A/S
- Operator Number
- 2182204
- Address
- Lautrupbjerg 7
- City
- Ballerup
- State
- Hovedstaden
- Postal Code
- 2750
- Country
- DK
- Correspondent
- Pernille Bartel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 1989-05-31 |
Proprietary Names
Achieve
Imagine
Forte
Ally
Magna
Promise
Rely
Trust
Flyte
Celebrate
Sport Lock
Cala
AGXR-Y
AGXR-L
Smart Fit
Key
Vea
Enhance Pro 10
Peak Pro 9
Solus Pro
SureFit,transducer module with receiver in the ear
DAI ADAPTOR 2
Nexia
Bold
ONE
Peak 7
Solus Max
Enhance Pro 20
Wax Guard
Aventa
XE BeMore
LiNX 3D
Ear Mold
Vida
Lex 800-M
Enya
AGXR-XD
Origin
LiNX 2
Lex 400-M
OMNIA
Serene
Verso
SureFit,acoustic tubing
AGXR-XB
Legend
AGXR-XF
Transducer module with receiver in the ear
SureFit,domes
SureFit CROS/BICROS
Dome
SureFit,sport lock
AGXR-T
Hearing Aid Battery
Sentry
CS Smart Fit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)