BCB Medical Oy

Certificate FI23/0000002

Rev. Issue 5Supplemented

Valid until: Jan 22, 2027

Certificate FI23/0000002 is a valid Quality management system issued to BCB Medical Oy and registered in EUDAMED. Valid until January 22, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: FI23/0000002
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 5
Certificate ID: 0598FI23/0000002Issue 5

Validity

Issued: Mar 7, 2025
Valid from: Mar 7, 2025
Valid until: Jan 22, 2027

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
Notified body country: Finland

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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

FI23/0000002Quality management systemSupplementedOct 18, 2024 → Jan 22, 2027

Scope coverage

Class IIa2

2 scopes

Disease specific register software and services
Class IIa
Disease specific register software (80 variants)
Class IIa

Documents

LanguagesEN