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4a medikal

by Dort-A Tip Malz San Ith Ihr Tic Ltd Sti 118 variants

Ref 4AFP200300

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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 Number86811764SW2 Basic UDI-DI 08681176415328UDI-DIDate12 Oct 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Düz Sterilizasyon Rulosu 450 mm x 200 m, 60g 2 İndikatörlü
Model / Reference
4AFP200300
Primary DI / UDI-DI
08681176415328
Basic UDI-DI
86811764SW2
Direct Marketing DI
08681176415328
EMDN Code
S01010101 Sterilisation pouches, flat, paper/plastic film
Device Class
Class I
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
TR-MF-000019642

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Properties

Other properties (13)

  • Sterile: No
  • 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