Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029906222

FEI Number

3029906222

Entity Name

ADHE-ELS INTERNATIONAL

City/State/Country

Kalaa Kebira Sousse, TN

Establishment Address

Km 128, Z.I., BP 84, Kalaa Kebira Sousse 4060, TN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Adhe-Els International (Owner Number: 10088762)

Owner / Operator Contact Address

Km 128, Z.I., BP 84, Kalaa Kebira, TN-51 4060, TN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

X-Flow Folysil Silicone Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2023-10-09
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2023-10-09

Official Correspondent

Mariem Gaaloul

US Agent Details

Brian Schmidt Business: Coloplast Email: usbes@coloplast.com Phone: (612) 8651177

Related Public Records

Same Entity

Adhe-Els International

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23

Similar Registrations

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3004070478	URO TECHNOLOGY SDN. BHD.	PONTIAN Johor, MY
3014650073	Silq Technologies Corporation	Sunny Isles Beach, FL, US
1018233	C.R. BARD, INC.	COVINGTON, GA, US
3010400865	WELL LEAD MEDICAL CO. LTD	GUANGZHOU Guangdong, CN
3015997711	KATMAI INTEGRATED SOLUTIONS	Brilliant, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029906222. Last updated year: 2026. Please use registration number 3029906222 when referencing this establishment in official correspondence.