biosurfit SA

Portugal PT-MF-000033920 Last updated 8 Jun 2026

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Devices: 13
Registries: EUDAMED
FDA recalls: 0

Catalogue13

CHARMcm® Ref 910401

Class B EUDAMED Active
CHARMcm® Ref 840300

Class B EUDAMED Active
At-home Lab Testing Ref AHLT_006

Class A EUDAMED Active
At-home Lab Testing Ref AHLT_001

Class A EUDAMED Active
At-home Lab Testing Ref AHLT_004

Class A EUDAMED Active
At-home Lab Testing Ref AHLT_002

Class A EUDAMED Active
At-home Lab Testing Ref AHLT_003

Class A EUDAMED Active
At-home Lab Testing Ref AHLT_005

Class A EUDAMED Active
spinit® Ref 240300

IVD General EUDAMED Active
spinit® Ref 950105

Class A EUDAMED Active
CHARMcm® Ref CHARM01

Class A EUDAMED Active
spinit® Ref 140300

IVD General EUDAMED Active
spinit® Ref 950200

Class A EUDAMED Active
spinit® S Ref spinitS

Class A EUDAMED Active
spinit® Ref 910201

IVD General EUDAMED Active

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

Notified body 2797 2 certificates

IVDR 827346 Issued

Quality management system EU IVDR

Issued
25 Sep 2026

Expires
24 Sep 2031
IVDR 827348 Issued

Technical documentation EU IVDR

Issued
25 Sep 2026

Expires
24 Sep 2031

Notified bodies

Notified body 2797

Information

Country: Portugal
Address: 66, Rua 25 de Abril, Azambuja, Portugal
Website: biosurfit.com
Email: [email protected]
PRRC contact: João Fonseca
EUDAMED SRN: PT-MF-000033920