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Cévka pro novorozence s nízkou porodní hmotností CN-01 M

by GAMA GROUP a.s.

Ref V646959-M

Active European Union

CE MDR

Valid until

29 Apr 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number26 0129 QR/NB Date30 Apr 2026IssuedStatusActive expires 29 Apr 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 26 0129 QR/NB Active

    Quality management system EU MDR

    Certifier
    INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 1023
    Issued
    30 Apr 2026
    Expires
    29 Apr 2031

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Cévka pro novorozence s nízkou porodní hmotností
Model / Reference
V646959-M
Primary DI / UDI-DI
08593540514974
Basic UDI-DI
85935406TF23NOVOROZENCNGX
EMDN Code
V028002 Neonatology care kits
Device Class
Class IIa
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000011894

Other devices from GAMA GROUP a.s.

See all devices from GAMA GROUP a.s. →

Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No