FDA Registration
Active
🇺🇸 United States
Amplifon REMOTE MICROPHONE 2 2.4 GH LE UNBRANDED ST
Reg #: 3019622583
·
FEI: 3019622583
·
Expires 2025
Products
1
Proprietary Names
139
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 With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2013-01-28 |
Proprietary Names
Amplifon REMOTE MICROPHONE 2 2.4 GH LE UNBRANDED ST
StarLink Edge Remote Microphone
Miracle-Ear MELINK MIC BL+ LE BRANDED PKG ST
KINDstarLink Mikrofon 2
NuEar NOW
Starkey Wi Series
Starkey Z Series
NuEar iNow
MicroTech MicroLens Synergy
Audibel A3
Audibel A3i
Starkey 3 Series
Starkey Xino
MicroTech Summit
Starkey Ignite
Starkey SoundLens Synergy
Audibel Start
NuEar SDS II
Starkey Axio
Nu Ear iSDS
MicroTech Kinnect 2
Audibel A2
Starkey Halo
NuEar Miniscopic Synergy
NuEar Circa AI
Starkey Muse
MicroTech Kinnect
Starkey Xperia
Audibel Axio
Starkey Halo 2
NuEar Axio
Audibel A4i
Starkey Tour
Audibel Invisibel Synergy
Audibel A4
NuEar Circa
Starkey livio
Audibel AI
MicroTech Thrive
NuEar iNOW iQ
MyDo M iQ
NuEar canvas
Audibel Via
MicroTech esentia AI
MicroTech portrait
Starkey livio AI
Starkey Picasso
Audibel DaVinci
Starkey Halo iQ
Starkey Muse iQ
NuEar NOW iQ
Audibel A4i iQ
Audibel Via AI
MicroTech Summit iQ
MicroTech esentia
Audibel Via Edge AI
MicroTech Kinnect iQ
Audibel A4 iQ
Starkey Livio Edge AI
Starkey Evolv AI
Starkey SoundGear Phantom
NuEar Circa Edge AI
MicroTech Esentia Edge AI
Miracle-EarBLISS MEMINI
Starkey Model S
MicroTech Envy AI
Audibel Arc AI
Miracle-EarBLISS MEEASY BTE 13 POWER PLUS
NuEar Savant AI
Miracle-EarCHARGE fullpower RIC/BTE T AV
Miracle-EarBLISS MEENERGY CROS RIC R
MicroTech Model M
NuEar Model N
Miracle-EarCHARGE fullpower RIC/BTE PWR AV
Starkey Premium Standard Charger
Amplifon ampli-energy
Starkey Premium Custom Charger
Miracle-EarBLISS MEENERGY BTE R
Starkey Standard Charger
Miracle-EarCHARGE start custom AV
Miracle-EarBLISS MECONNECT BTE 13 POWER PLUS
Miracle-EarCHARGE fullpower custom PWR AV
NUEAR NE NXG AI
Audibel Model A
Miracle-EarCHARGE start RIC/BTE AV
Miracle-EarLINK Mic+ AV
Miracle-EarLINK TV Streamer AV
Miracle-EarBLISS MEENERGY RIC R
StarLink Remote Control
Miracle-EarBLISS MEENERGY ITC R
StarLink Custom Charger 2
Miracle-EarLINK Remote Mic AV
Starkey Custom Charger
Miracle-EarLINK Remote AV
StarLink Remote Microphone +
StarLink charger 2
Starkey Genesis AI CIC
Starkey Signature Series
MicroTech Signature Series
StarLink Remote Control 2
StarLink Premium Standard Charger 2
Audibel Signature Series
AUDIOSYNC INTRIGUE AI
StarLink Premium Custom Charger 2
Kind KINDvaro
NuEar Signature Series
Audiosync Edge AI
Amplifon AMPLI-ENERGY
MELINK TV STREAMER BL+ LE ST
NuEar Edge AI
Miracle-EarBLISS RIC R-S
KINDsignature
AudioSync Signature Series
Starkey Genesis AI RIC 312
Afflelou Incognito Edge AI
Audibel Vitality AI
STARKEY GENESIS AI
Miracle Ear MEMINI
StarLink TV Streamer
AMPLITV Streamer
Amplifon AMPLI-MINI
Audigy AGXs Signature Series
MICROTECH MT NXG AI
SurfLink Programmer
Miracle-EarLINK Remote Microphone +
AUDIBEL INTRIGUE AI
AUDIGY AGXS GENESIS AI
StarLink Mini Remote Microphone
Audigy AGXS Edge AI
Amplifon AMPLI-CONNECT
AMPLI-TV 2 LE ST
Miracle Ear MECROS
StarLink Edge TV Streamer
Starkey Edge AI
OuieZen
KINDstarLink Edge TV Adapter 2
Amplifon AMPLI-CROS
Miracle Ear MEENERGY
Miracle Ear MECONNECT
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device