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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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AVEFLOR, a.s.

Certificate 25 0380 QR/NB

Issued
Valid until
Sep 25, 2030

Overview

Certificate number
25 0380 QR/NB
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
102325 0380 QR/NB

Validity

Issued
Sep 26, 2025
Valid from
Sep 26, 2025
Valid until
Sep 25, 2030

Manufacturer

Manufacturer
AVEFLOR, a.s.
Manufacturer SRN
CZ-MF-000003103
Manufacturer country
Czechia

Notified body

Notified body
INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
Notified body SRN
1023
Notified body country
Czechia

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
Yes
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

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa4

4 scopes

  • AKUTOL™
    Class IIa
  • AKUTOL™ spray
    Class IIa
  • AKUTOL™ STOP spray
    Class IIa
  • AKUTOL™ Burn spray
    Class IIa

Documents

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