Elde Medikal Sanayi Ve Ticaret Anonim Sirketi
TürkiyeFDA applicant, unverified FDA FEI 3046649655
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Elde Medikal Sanayi Ve Ticaret Anonim Sirketi makes
Elde Medikal produces reusable adhesive electrodes for medical electrotherapy, including standard sizes (5 cm × 5 cm and 5 cm × 10 cm) designed for transcutaneous electrical nerve stimulation (TENS) and other electrotherapeutic applications.
The company’s electrodes are classified as Class II devices under global regulatory frameworks and are listed via FDA 510(k) clearance in the United States. Elde Medikal is headquartered in Turkey.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3046649655
- DUNS number
- 503009295
- Address
- Necip Fazil Bulvari Keyap Carsi Sitesi No: 44, Umraniye Istanbul
Frequently asked questions
How many devices does ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI have in the registry?
The registry currently lists 3 devices for ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI. Devices recorded under merged duplicate company entries are counted once.
Which registries list ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI's devices?
Among its 3 most recently registered devices, ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI's devices fall under?
Among its 3 most recently registered devices, the classes recorded for ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI in the registry?
The most recently registered devices listed for ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI include Elde Medical ELDT5-04, Elde Medical ELDT5-20 and Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode).