Blog Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Blog Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

MD Atlas
Documents

ALFAMEDIC s.r.o.

Certificate 2025-MDR/QS-031

Rev. 0Issued

Valid until: Jun 3, 2030

Overview

Certificate number: 2025-MDR/QS-031
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-0310

Validity

Issued: Jun 3, 2025
Valid from: Jun 3, 2025
Valid until: Jun 3, 2030

Manufacturer

Manufacturer: ALFAMEDIC s.r.o.
Manufacturer SRN: CZ-MF-000037764
Manufacturer country: Czechia

Notified body

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

Covered devices

Heated bed for newborns and infantsClass IIb
859420147VL22F001MT

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

Neonatal radiant warmers
Class IIb
DEVICE
Class IIb

Documents

LanguagesCSEN