FDA device listing
99047356,99404876,Alsophila 99047356,BH55 BH-R55 ER02,DAB006,FT-09E FT-09F FT-03B FT-15A…
FDA device listing 1034005675 · Eran Technology (Shenzhen) Co.,Limited
Key facts
| Proprietary names | 99047356,99404876,Alsophila 99047356,BH55 BH-R55 ER02,DAB006,FT-09E FT-09F FT-03B FT-15A FT-04A,FT-O04,FT-O05,FT-O06,InsisCare 99404876,IR5,JLH1,KANAD JEC PRO,KANAD JEC PRO II,TC1600-02Y TC1600-03Y TC1600-04Y TC1600-08Y TC1600-09Y TC1600-11Y TC1600-15Y,TC1600-N12,TC1600-O01,TC1600-O03,TC1600-P19,TC1600-P25,TC1600 TC1600-P16 TC1600-P23 TC1600-P24 TC1600-N8 TC1600-N11 TC1600-N15 TC1600-B09… |
|---|---|
| Owner/operator | Eran Technology (Shenzhen) Co.,Limited |
| Owner/operator number | 10086736 |
| Product codes | QUG |
| Device names | QUG - Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3305 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Eran Technology (Shenzhen)Co.,Limited |
| Establishment registrations | 3021456527 |
| FEI numbers | 3021456527 |
| Establishment operations | Contract Manufacturer, 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