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Revaclear 500

by Vantive Health GmbH

Ref Revaclear 500

Revaclear 500 is a device classified as Class IIb in the EU and Class II in the US made by Vantive Health GmbH, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 7332414VA00001934), cleared under FDA 510(k) K213639 on 24 Jan 2022 and listed in FDA GUDID since 29 May 2026 (UDI-DI 07332414200183), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213639

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07332414200183 UDI-DI Date29 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number7332414VA00001934 Basic UDI-DI 07332414200183UDI-DIDate27 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213639 Date24 Jan 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7332414VA00001934 registered 27 May 2026 Active
  • FDA 510(k) K213639 decided 24 Jan 2022 Active
  • FDA GUDID UDI-DI 07332414200183 listed 29 May 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213639
  2. Registered EUDAMED 7332414VA00001934
  3. Listed FDA GUDID 07332414200183

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Revaclear 500 EUDAMED
Revaclear GUDID
Generic name
Hollow-fibre haemodialysis dialyser, single-use
Model / Ref / Catalog
Revaclear 500, 955543A
Primary DI / UDI-DI
07332414200183
Basic UDI-DI
7332414VA00001934
510(k) Number
FDA product code
KDI
EMDN code
F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES
GMDN term
Hollow-fibre haemodialysis dialyser, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.5860
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 2.1 Square meter

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.

Manufacturer details

EUDAMED SRN
CH-MF-000038981
Authorised representative
Vantive S.r.l. IT-AR-000041309

Similar devices in this category

Other devices filed under DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES.

Other devices from Vantive Health GmbH

See all devices from Vantive Health GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)