Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005346382

FEI Number

3005346382

Entity Name

Transcendencias Comerciales S.L

City/State/Country

Ergobia-Astigarraga Guipuzcoa, ES

Establishment Address

C/ Troya Ibilbidea 16, Nave 5A8/5B8, Ergobia-Astigarraga Guipuzcoa 20115, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Transcendencias Comerciales S.L (Owner Number: 10021855)

Owner / Operator Contact Address

C/Zubiberri 31- Planta baja local 1, San Sebastian, ES-SS 20018, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131852

PMA Number

N/A

All Registered Proprietary Names

Small Hydrokit Segmented Hose / Hydrokit with limiter Hydrokit with limiter HC-1 Classic Segmented Hose / Large Hydrokit HC-1 Large Hydrokit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPL	Colonic Irrigation System	Gastroenterology, Urology	Class 2	876.5220	2014-05-13

Official Correspondent

Ramon Echevarria

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

Transcendencias Comerciales S.L

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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1320894	CONMED CORPORATION	Utica, NY, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005346382. Last updated year: 2026. Please use registration number 3005346382 when referencing this establishment in official correspondence.