"Biofaktor" Sp. z o. o.

Certificate HZ 1023871-1

Rev. 1Supplemented

Valid until: Feb 5, 2031

Certificate HZ 1023871-1 is a valid Quality management system issued to "Biofaktor" Sp. z o. o. and registered in EUDAMED. Valid until February 5, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1023871-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 1023871-11

Validity

Issued: Apr 28, 2026
Valid from: Apr 28, 2026
Valid until: Feb 5, 2031

Manufacturer

Manufacturer: "Biofaktor" Sp. z o. o.
Manufacturer SRN: PL-MF-000027226
Manufacturer country: Poland

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 1023871-1Quality management systemIssuedFeb 6, 2026 → Feb 5, 2031

Scope coverage

Class IIb2

2 scopes

G05 – Gastrointestinal devices, Topical anorectal administered gastrointestinal system devices
Class IIb
U0803 -Vaginal devices in the form of solutions/creams/ova/tablets
Class IIb

Documents

LanguagesEN