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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

Seerlinq s.r.o.

Certificate 2025-MDR/QS-013

Rev. 0Issued

Valid until: Feb 7, 2030

Overview

Certificate number: 2025-MDR/QS-013
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652025-MDR/QS-0130

Validity

Issued: Feb 7, 2025
Valid from: Feb 7, 2025
Valid until: Feb 7, 2030

Manufacturer

Manufacturer: Seerlinq s.r.o.
Manufacturer SRN: SK-MF-000040803
Manufacturer country: Slovakia

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

SEERLINQ HeartCoreClass IIb
8588009909SeerlinqHCWA

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
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: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

Cardiac telemetry instruments - medical device software
Class IIb
DEVICE
Class IIb

Documents

LanguagesENSK