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Gauze Ball with X-ray thread 60mm á5pcs

by BATIST Medical Productions s.r.o.

Ref 123011063A

Active European Union

CE MDR

Valid until

11 Oct 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number26 0314 QR/NB Date12 Oct 2026IssuedStatusActive expires 11 Oct 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 26 0314 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
    12 Oct 2026
    Expires
    11 Oct 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sterile Gauze Products Iia
Model / Reference
123011063A
Primary DI / UDI-DI
08596222031271
Basic UDI-DI
8596222CEdoc04FT
EMDN Code
M0201050201 Cotton gauze pads, with x-ray detectable thread, sterile
Device Class
Class IIa
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000023495

Other devices from BATIST Medical Productions s.r.o.

See all devices from BATIST Medical Productions s.r.o. →

Properties

  • Sterile

Other properties (12)

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