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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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MD Atlas
Documents

Bactiguard AB

Certificate 2253382CE01

Rev. Rev. 0Issued

Valid until: Jan 1, 2028

Overview

Certificate number: 2253382CE01
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03442253382CE01Rev. 0

Validity

Issued: Jan 9, 2023
Valid from: Jan 9, 2023
Valid until: Jan 1, 2028

Manufacturer

Manufacturer: Bactiguard AB
Manufacturer SRN: SE-MF-000020790
Manufacturer country: Sweden

Notified body

Notified body: DEKRA Certification B.V.
Notified body SRN: 0344
Notified body country: Netherlands

Covered devices

BIP Foley Catheter - LatexClass IIb
7333330FOLEYLATUV110301Z9

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

DEVICE
Class IIb

Documents

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