FDA Registration
Active
🇺🇸 United States
Touch Keyboard
Reg #: 2113281
·
FEI: 2113281
·
Expires 2025
Products
1
Proprietary Names
62
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DIAGNOSTIC GROUP LLC
- Registration Number
- 2113281
- FEI Number
- 2113281
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 10395 W 70th St
- City
- EDEN PRAIRIE
- State
- MN
- ZIP
- 55344
- Country
- US
Owner / Operator
- Firm Name
- DEMANT A/S
- Operator Number
- 8010048
- Address
- KONGEBAKKEN 9, --
- City
- SMORUM
- State
- DK-NOTA
- Postal Code
- DK-2765
- Country
- DK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 1994-09-21 |
Proprietary Names
Touch Keyboard
Welch Allyn AM282
GSI AMTAS
MA41
MA40
RA660
Detective
Amplivox 160
GSI AudioStar Pro
Avant A2D+ Audiometer
Amplivox 170
GSI 17
MA33
Amplivox 240
GSI AMTAS Flex
MA28
MA42
Amplivox 270
AC33
AD226
AS608
PA5
MA25
AD229
GSI 18
Avant Stealth Audiometer
Amplivox 260
MA52
MA1
Amplivox 116
MA27
AC40
GSI Pello
GSI 61
MA39
AM282
Wizard Ultra
AD629
Avant ARC
AD528
Luna
RA360
CCA-200mini Audiometer
Fit Test Audiometer
SMART TONE Audiometer
CCA-100mini Audiometer
NEXT Audiometer
modelONE
Amplivox 270+
easyTone
Amplivox PC850
Amplivox Otosure
CIR Insert earphone
B-81 Bone conductor headset
DD450 High frequency headset
DD45 Headset
B71 Bone conductor headset
TDH39 Headset
IP30 Insert earphone
DD65 Headset
Equinox Evo
DD65v2 Audiometric headset
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)