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Ritus 8888413419

by Mozarc Medical US LLC

Ref 8888413419

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10884521852938 Basic UDI-DI 10884521852938UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521852938 UDI-DI Date27 Nov 2025ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ritus™ Peritoneal Dialysis Catheter Swan Neck Missouri Curl Cath, 2 Cuff Right 62.5 cm EUDAMED
Ritus GUDID
Generic Name
Peritoneal dialysis catheter, acute/chronic
Model / Reference
8888413419
Primary DI / UDI-DI
10884521852938
Basic UDI-DI
B-10884521852938
510(k) Number
FDA Product Code
FJS
EMDN Code
F900101 Peritoneal dialysis catheters and kits
GMDN Term
Peritoneal dialysis catheter, acute/chronic
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5630
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 62.5 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes

Related devices

Cleared under the same submission (K862046)

Show all (12)

Other devices from Mozarc Medical US LLC

See all devices from Mozarc Medical US LLC →

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No