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Argyle™ Chronic Catheter Accessory Injection Sealing Cap

by Mozarc Medical US LLC

Ref 8813791001Model Dialysis Accessories

Active European Union

CE MDD

Valid until

No date given

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-20884521003948 Basic UDI-DI Date30 Oct 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Trade name
Argyle™ Chronic Catheter Accessory Injection Sealing Cap
Ritus™ Chronic Catheter Accessory Injection Sealing Cap
Model / reference
Dialysis Accessories, 8813791001
Primary DI / UDI-DI
20884521003948, 20884521811284
Basic UDI-DI
B-20884521003948, B-20884521811284
EMDN code
F9080 Dialysis devices - other accessories
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000043425
Authorised representative
Mozarc Medical Ireland Ltd. IE-AR-000048547

Other devices from Mozarc Medical US LLC

See all devices from Mozarc Medical US LLC →

Properties

  • Supplied sterile

Other properties (11)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No