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Ristocetin

by HYPHEN BioMed 2 variants

Ref AG004KModel Platelet Aggregation -Ristocetin

Ristocetin (AG004K) is a Class C device made by Hyphen Biomed, registered in EUDAMED on 18 Sep 2026 (Basic UDI-DI 366353700039BG), active as of 22 Oct 2026.

Active European Union

CE IVDR

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number366353700039BG Basic UDI-DI Date18 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / reference
Platelet Aggregation -Ristocetin, AG004K
Primary DI / UDI-DI
03663537086397, 03663537048777
Basic UDI-DI
366353700039BG
EMDN code
W0103020401 Aggregation reagents
Device class
Class C
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000002214

Similar devices in this category

Other devices filed under PLATELET FACTORS.

Other devices from Hyphen Biomed

See all devices from Hyphen Biomed →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • New device
Other properties (9, all answered No)