FDA device listing
2000 Primus HIT Pro,2005-1 HIT Unit,HIT - Measure by Otometrics,HIT Unit,Measure by Otometrics - HIT,OTOPro,Primus…
FDA device listing 1477694299 · Auditdata A/S
Key facts
| Proprietary names | 2000 Primus HIT Pro,2005-1 HIT Unit,HIT - Measure by Otometrics,HIT Unit,Measure by Otometrics - HIT,OTOPro,Primus Hearing instrument test unit - PHITU,Unity 3 HIT Unit |
|---|---|
| Owner/operator | Auditdata A/S |
| Owner/operator number | 10032598 |
| Product codes | ETW |
| Device names | ETW - Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3310 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Auditdata A/S, Auditdata, LLC, Inission Syd AB (Malmo AB), Nordes Sp. z o.o. |
| Establishment registrations | 3004052117, 3008386587, 3013596041, 3030089857 |
| FEI numbers | 3004052117, 3008386587, 3013596041, 3030089857 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Foreign Private Label Distributor, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database