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Sanakin

by Санакин Биосайънс Еоод Bulgaria EUDAMED

Ref SBT2010PP23

EMDN B0599

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3800502422SBT2010PP23AL Basic UDI-DIDate22 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Sanakin® Autologous serum procedure pack
Model / Reference
SBT2010PP23
Primary DI / UDI-DI
03800502422006
Basic UDI-DI
3800502422SBT2010PP23AL
EMDN Code
B0599 Topical use blood components preparation devices - other
Device Class
Class IIa
Medical Purpose
Sanakin® Autologous serum procedure pack is intended for the ex vivo preparation of autologous serum from venous blood collected from the same patient, for subsequent local administration or re-administration to that patient by a qualified healthcare professional in accordance with the applicable clinical protocol. The device itself is not intended for direct patient connection, injection, infusion or in vivo use. No specific disease indication is claimed for Sanakin® Autologous serum procedure pack. The clinical indication and patient selection for the use of the prepared autologous serum are determined by a qualified healthcare professional within the validated and approved clinical protocol.

Manufacturer details

EUDAMED SRN
BG-PR-000032483

Other devices from Санакин Биосайънс Еоод

Properties & raw data

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

Sources (1)

  • EUDAMED 60508d38-fdd5-425b-a605-3cf2f5d2f3cd 61 fields · synced 23 Oct 2026