FDA device listing
Anaton - TIE 60 Champagne - 8682549137229,Anaton - TIE 60 Silver - 8682549139292,Anaton - TIE 70 Champagne…
FDA device listing 1538461974 · EARTEKNIK ISITME VE ODIOMETRI CIHAZLARI SAN. vE TIC. A.S
Key facts
| Proprietary names | Anaton - TIE 60 Champagne - 8682549137229,Anaton - TIE 60 Silver - 8682549139292,Anaton - TIE 70 Champagne - 8682549137236,Anaton - TIE 70 Silver - 8682549139308,Anaton - TIE 80 Champagne - 8682549137243,Anaton - TIE 80 Silver - 8682549139315,Anaton - Tie 90 - Beige - 8683873081325,Anaton -Tie 90 - Beige - 8683873081325,Anaton - TIE 90 Champagne - 8682549137250,Anaton - TIE 90 Silver… |
|---|---|
| Owner/operator | EARTEKNIK ISITME VE ODIOMETRI CIHAZLARI SAN. vE TIC. A.S |
| Owner/operator number | 10080092 |
| Product codes | ESD |
| Device names | ESD - Hearing Aid, Air-Conduction, Prescription |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.3300 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | EARTEKNIK ISITME VE ODIOMETRI CIHAZLARI SAN. VE TIC. A.S |
| Establishment registrations | 3015990335 |
| FEI numbers | 3015990335 |
| Establishment operations | 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