Elde Medical ELDT5-04

by Elde Medikal Sanayi Ve Ticaret Anonim Sirketi

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08682250582004 UDI-DI	Date8 Jul 2026Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Elde Medical
Generic Name: Transcutaneous electrical stimulation electrode, single-use
Model / Reference: ELDT5-04

Primary DI / UDI-DI: 08682250582004
510(k) Number: K253237
FDA Product Code: GXY
GMDN Term: Transcutaneous electrical stimulation electrode, single-use

Device Class: Class II
Regulation Number: 882.1320
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Unsafe

Other devices from Elde Medikal Sanayi Ve Ticaret Anonim Sirketi

Elde Medical ELDT5-20

Class II
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

Class II

Properties

Prescription Use
Over-the-Counter
Lot / Batch Number
Expiration Date

Other properties (10)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No