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Ritus 8810807001

by Mozarc Medical US LLC

Ref 8810807001Model Dialysis Accessories

Ritus 8810807001 is a device classified as Class IIb in the EU and Class II in the US made by Mozarc Medical US LLC, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-10884521811102), cleared under FDA 510(k) K780449 on 16 May 1978 and listed in FDA GUDID since 27 Nov 2025 (UDI-DI 10884521811102), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K780449

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10884521811102 Basic UDI-DI 10884521811102UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521811102 UDI-DI Date27 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK780449 Date16 May 1978DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10884521811102 registered 6 Nov 2026 Active
  • FDA 510(k) K780449 decided 16 May 1978 Active
  • FDA GUDID UDI-DI 10884521811102 listed 27 Nov 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K780449
  2. Listed FDA GUDID 10884521811102
  3. Registered EUDAMED B-10884521811102

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Ritus™ Peritoneal Dialysis Accessory Medical Grade Silicone Adhesive, Type A EUDAMED
Ritus GUDID
Generic name
Medical device adhesive
Model / reference
8810807001, Dialysis Accessories
Primary DI / UDI-DI
10884521811102
Basic UDI-DI
B-10884521811102
510(k) Number
FDA product code
FJS
EMDN code
F9080 Dialysis devices - other accessories
GMDN term
Medical device adhesive
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.5630
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Cleared under the same submission (K780449)

Similar devices in this category

Other devices filed under DIALYSIS DEVICES - VARIOUS.

Other devices from Mozarc Medical US LLC

See all devices from Mozarc Medical US LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)