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Sterile wound dressing

by RFX+CARE Manufacturing Co., Ltd. 14 variants

Ref FA200-9086Model 5x5cm 7.5cmx7.5cm 10x10cm 10x15cm etc

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 linked in EUDAMED

A group certificate may exist

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 Number69228209MDN1204IS0000357Q Basic UDI-DI 06922820990863UDI-DIDate8 Sep 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
5x5cm 7.5cmx7.5cm 10x10cm 10x15cm etc, FA200-9086
Primary DI / UDI-DI
06922820990863
Basic UDI-DI
69228209MDN1204IS0000357Q
EMDN Code
M040204 Non-adherent absorbent dressings
Device Class
Class I
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000002971
Authorised representative
RFX+Care International A/S DK-AR-000001768

Other devices from RFX+CARE Manufacturing Co., Ltd.

See all devices from RFX+CARE Manufacturing Co., Ltd. →

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