FDA Registration
Active
🇺🇸 United States
Starkey S Series
Reg #: 3019622583
·
FEI: 3019622583
·
Expires 2025
Products
1
Proprietary Names
59
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Starkey Global Distribution Center
- Registration Number
- 3019622583
- FEI Number
- 3019622583
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3810 Plainfield Road, Suite#112
- City
- Plainfield
- State
- IN
- ZIP
- 46168
- Country
- US
Owner / Operator
- Firm Name
- Starkey Laboratories, Inc.
- Operator Number
- 2125608
- Address
- 6700 Washington Ave S, --
- City
- Eden Prairie
- State
- MN
- Postal Code
- 55344
- Country
- US
- Correspondent
- Brian Dahl
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2007-06-12 |
Proprietary Names
Starkey S Series
MicroTech Summit
Aries
NuEar NOW
MicroTech Propel
Aries Pro
NuEar Intro
DP 7
Starkey Ignite
Starkey SoundLens Synergy
Starkey X Series
Starkey Muse
Audibel Invisibel Synergy
DP 7+
Starkey Destiny
AMP
NuEar Miniscopic Synergy
Starkey 3 Series
NuEar Axio
MicroTech MicroLens Synergy
DP 8
Starkey E Series
Audibel A4
Starkey Xino
NuEar SDS
Starkey Axio
Audibel Axio
Starkey Halo iQ
MicroTech portrait
Starkey Picasso
Starkey Tour
Audibel A4i iQ
Audibel A4 iQ
NuEar NOW iQ
NuEar iNOW iQ
NuEar canvas
MicroTech Kinnect iQ
MicroTech Summit iQ
Starkey Muse iQ
Audibel DaVinci
Amplifon ampli-mini
Starkey Evolv AI
Miracle-EarBLISS MEMINI NWL CIC 10 EV ST
Miracle-EarBLISS MEMINI IIC
NUEAR NE NXG AI
AMPLI-MINI Signature Series
KINDsignature
Audibel Signature Series
AUDIOSYNC INTRIGUE AI
Starkey Signature Series
NuEar Signature Series
MicroTech Signature Series
MEMINI Signature Series
AudioSync Signature Series
STARKEY GENESIS AI
MICROTECH MT NXG AI
AUDIGY AGXS GENESIS AI
AUDIBEL INTRIGUE AI
Audigy AGXs Signature Series
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device