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4a medikal

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

Ref 4AFR200200/60/2

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number869744275SJD Basic UDI-DI 08697442750062UDI-DIDate11 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  • Withdrawn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
Flat Sterilization Roll 100 mm x 200 m, 60g with 2 Indicators
Model / Reference
4AFR200200/60/2
Primary DI / UDI-DI
08697442750062
Basic UDI-DI
869744275SJD
Direct Marketing DI
08697442750062
EMDN Code
S01020101 Flat sterilisation reels, 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