FDA device listing
3000 Real Ear,3000 Real Ear - IN1,IN1 Insert Earphone
FDA device listing 1417971096 · Auditdata A/S
Key facts
| Proprietary names | 3000 Real Ear,3000 Real Ear - IN1,IN1 Insert Earphone |
|---|---|
| Owner/operator | Auditdata A/S |
| Owner/operator number | 10032598 |
| Product codes | ETT |
| Device names | ETT - Cushion, Earphone (For Audiometric Testing) |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.1100 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Auditdata A/S, Auditdata, LLC, Nordes Sp. z o.o. |
| Establishment registrations | 3004052117, 3008386587, 3030089857 |
| FEI numbers | 3004052117, 3008386587, 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