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Endoret Kits_professional User

by B.T.I. Biotechnology Institute, S.l Spain EUDAMED

Ref EDK1

EMDN B019001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84353898PRGFENDORET-KITL4 Basic UDI-DIDate7 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Endoret Kits_professional User
Model / Reference
EDK1
Primary DI / UDI-DI
08435389830122
Basic UDI-DI
84353898PRGFENDORET-KITL4
EMDN Code
B019001 Platelet gel and fibrin glue production bags and kits
Device Class
Class IIb
Medical Purpose
For obtaining autologous platelet-rich plasma (PRP).

Manufacturer details

EUDAMED SRN
ES-PR-000001719

Other devices from B.T.I. Biotechnology Institute, S.l

See all devices from B.T.I. Biotechnology Institute, S.l →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 08435389830122|84353898PRGFENDORET-KITL4 61 fields · synced 25 Oct 2026