Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010659128

FEI Number

3010659128

Entity Name

PROMEDTECH

City/State/Country

Fouchena Tunis, TN

Establishment Address

ZI MGHIRA 2, Fouchena Tunis 2082, TN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PROMEPLA (Owner Number: 9092365)

Owner / Operator Contact Address

9 AVENUE ALBERT II, --, MONACO, MC-MO 98000, MC

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tubing, with filter, sterile, for insufflation soring inc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2021-12-07
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2007-08-01
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2026-03-18

Official Correspondent

kim HERBERT

US Agent Details

Chuck Philipp Email: chuckp@sundance17.net Phone: (720) 3404733

Related Public Records

Same Entity

PROMEPLA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011816507	EMOTECHNIC	Casablanca, MA
3006617533	PROMEPLA S.A.M	MONACO Monaco-Ville, MC

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010659128. Last updated year: 2026. Please use registration number 3010659128 when referencing this establishment in official correspondence.