Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042888450

FEI Number

3042888450

Entity Name

PLASTIC ELECTROMECHANIC COMPANY MEDICAL DEVICE

City/State/Country

Bir Mcherga Zaghouan, TN

Establishment Address

Lot 14, Zone industrielle 3, Djebel El Oust, 1141 Bir Mcherga, Zaghouan - Tunisie, Bir Mcherga Zaghouan 1141, TN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Plastic Electromechanic Company Medical Device (Owner Number: 10094737)

Owner / Operator Contact Address

Lot 14, Zone industrielle 3, Djebel El Oust, 1141 Bir Mcherga, Zaghouan - Tunisie, Bir Mcherga, TN-22 1141, TN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CLARAVUE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2025-12-19

Official Correspondent

Bilel Kraiem

US Agent Details

Jessica Potter Business: NISSHA MEDICAL TECHNOLOGIES Email: jpotter@nisshamedical.com Phone: (716) 8496367

Related Public Records

Same Entity

Plastic Electromechanic Company Medical Device

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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042888450. Last updated year: 2026. Please use registration number 3042888450 when referencing this establishment in official correspondence.