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Manufacturer/company:

Company Name

Roxtec International AB

Rombvägen 2
Lyckeby
Sweden

Number of projects
4
Number of test pieces
6
Phone

+46 455 36 67 00

Email

info@roxtec.com

Website

roxtec.com/en/products/certificates/roxtec-international-ab/

Documents

RO 2508-1666_Statement_02.pdf
Valid until 24.09.2030
Download
RO 2508-1666_Certificate_02.pdf
Valid until 24.09.2030
Download

Test piece

Name of test piece/s LABSEAL C LTX WITH COUNTER FRAME 0-40
Project number RO 2508-1666
Created on 11/12/2025
Valid until 09/24/2030
Test type Hygienic Design (EU GMP Annex 1; EHEDG Doc. 8; DIN EN 1672-2;  ISO 14159)
Classfication geeignet bis GMP-Klasse:C

Tests & results

Hygienic Design (EU GMP Annex 1; EHEDG Doc. 8; DIN EN 1672-2;  ISO 14159)

Hygienic design
(EU GMP Annex 1; EHEDG Doc. 8; DIN EN 1672-2; ISO 14159)

Suitability

up to GMP Class C

However, this recommendation only pertains to the operating utility when in a resting state. An overall assessment can only be made after its installation in the production environment.