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AccuFit Adhesive Housing, Oval Extra, 6 pack

by Freudenberg Medical LLC

Ref BE 6084-6, BE 6083-6

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08482530ACCUFITF7 Basic UDI-DI Date5 Nov 2025RegisteredStatusActive

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  • Withdrawn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

Trade Name
AccuFit Adhesive Housing, Oval Extra, 6 pack
AccuFit Adhesive Housing, Oval, 6 pack
Device Name
Accufit
Model / Reference
BE 6084-6, BE 6083-6
Primary DI / UDI-DI
00848253003603, 00848253003610
Basic UDI-DI
08482530ACCUFITF7
EMDN Code
R9080 Respiratory and anesthesia devices - accessories not included in other classes
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000023823
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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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