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CHRONO-PAR® Ristocetin

by Chrono-log Corp

Part of a family of 6 devices: see the family page

Ref 396 Ristocetin

CHRONO-PAR® Ristocetin (396 Ristocetin) is a device classified as Class A in the EU and Class II in the US made by Chrono-Log Corp, registered in EUDAMED on 7 Apr 2022 (Basic UDI-DI 081147601Reagents53), cleared under FDA 510(k) K922800 on 26 Aug 1992 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 00811476010086), active as of 22 Oct 2026.

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

CE IVDR 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) K922800

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081147601Reagents53 Basic UDI-DI 00811476010086UDI-DIDate7 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00811476010086 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK922800 Date26 Aug 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081147601Reagents53 registered 7 Apr 2022 Active
  • FDA 510(k) K922800 decided 26 Aug 1992 Active
  • FDA GUDID UDI-DI 00811476010086 listed 11 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K922800
  2. Listed FDA GUDID 00811476010086
  3. Registered EUDAMED 081147601Reagents53

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
CHRONO-PAR® Ristocetin EUDAMED
Chrono-Par GUDID
Generic name
Platelet aggregation study IVD, reagent
Device name
Reagents
Model / reference
396 Ristocetin EUDAMED
396 GUDID
Primary DI / UDI-DI
00811476010086
Basic UDI-DI
081147601Reagents53
510(k) Number
FDA product code
GHR
EMDN code
W01030199 Haematology reagents - other
GMDN term
Platelet aggregation study IVD, reagent
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.5700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
396 Ristocetin
GUDID
396
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A 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
US-MF-000018631
Authorised representative
BioTop Medical NL-AR-000012565

Similar devices in this category

Other devices filed under HAEMATOLOGY REAGENTS - OTHER.

Other devices from Chrono-Log Corp

See all devices from Chrono-Log Corp →

Properties

  • Reagent
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)