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CryoPur™ Solutions

by OriGen Biomedical Inc. EUDAMED

Active European Union

Ref CD-50, SD-10, SDS-05A-B, CP-70, SDS-15A-F, SP-30, CP-50, CP-50-T

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10816203022506 Basic UDI-DIDate26 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Cd-50
Sd-10
Sds-05A-B
Cp-70
Sds-15A-F
Sp-30
Cp-50
Cp-50-T
Model / Reference
CD-50, SD-10, SDS-05A-B, CP-70, SDS-15A-F, SP-30, CP-50, CP-50-T
Primary DI / UDI-DI
10816203022506, 20816203023548, 20816203023524, 10816203022568, 20816203023531, 20816203023494, 10816203022551, 10816203023459
Basic UDI-DI
B-10816203022506, B-20816203023548, B-20816203023524, B-10816203022568, B-20816203023531, B-20816203023494, B-10816203022551, B-10816203023459
EMDN Code
B06 Cellular or biological manipulation devices
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000018098
Authorised representative
Advena Limited MT-AR-000000234

Other devices from OriGen Biomedical Inc.

See all devices from OriGen Biomedical Inc. →

Properties

Show properties
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No