Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006517653

FEI Number

3006517653

Entity Name

COTTON HIGH TECH S.L.

City/State/Country

Balsareny Barcelona, ES

Establishment Address

Colonia La Rabeia, s/n, Balsareny Barcelona ES 08660, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COTTON HIGH TECH S.L. (Owner Number: 10021857)

Owner / Operator Contact Address

Colonia la Rabeia s/n, Balsareny, ES-B ES 08660, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COHITECH Cottonlock Tampons with Reusable Applicator COHITECH Reusable Tampon Applicator, Size 2 (super - super plus) COHITECH Reusable Tampon Applicator, Size 1 (regular - super) Organic Cotton Cardboard Applicator Tampons Super in Bulk Organic Cotton Carboard Applicator Tampons Regular in Bulk Organic Cotton Cardboard Applicator Tampons Super Plus in Bulk COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS Menstrual Cup COHITECH Menstrual cups S,M,L in bulk COHITECH Organic Cotton Non-Applicator Cottonlock Tampons Light, Regular, Super, Super Plus Organic Cotton Ultrathin Pantyliners wrapped individually in Bulk Organic Cotton Ultrathin DAY Pads with wings - wrapped individually - in Bulk Organic Cotton Ultrathin NIGHT Pads with wings Organic Cotton Ultrathin NIGHT Pads with wings - wrapped individually - in Bulk

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2022-06-10
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2021-12-23
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2009-12-09
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2025-12-29
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2017-04-19
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2021-10-27
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2007-10-03

Official Correspondent

Miriam Carrero Oller

US Agent Details

Kristi Leigh Business: Smith Associates Imports Email: kleigh@fdaconsultants.com Phone: (410) 8149993

Related Public Records

Same Entity

COTTON HIGH TECH S.L.

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
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02
K930149	Kimberly-Clark Corp.	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	1994-03-02
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006517653. Last updated year: 2026. Please use registration number 3006517653 when referencing this establishment in official correspondence.