FDA Registration
Active
🇺🇸 United States
2001 Primus Video Otoscope - PVO
Reg #: 3004052117
·
FEI: 3004052117
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Auditdata, LLC
- Registration Number
- 3004052117
- FEI Number
- 3004052117
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 88 Glocker Way, #352
- City
- Pottstown
- State
- PA
- ZIP
- 19465
- Country
- US
Owner / Operator
- Firm Name
- Auditdata A/S
- Operator Number
- 10032598
- Address
- Wildersgade 10B
- City
- Copenhagen
- State
- Hovedstaden
- Postal Code
- 1408
- Country
- DK
- Correspondent
- Christian Holmelund
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2014-08-18 |
Proprietary Names
2001 Primus Video Otoscope - PVO
Establishment Types
Complaint File Establishment per 21 CFR 820.198