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Gentle Flex Pro High Throughput Cell Processing System

by Shenzhen Cellbri Bio-Innovation Technology Co., Ltd. China EUDAMED

Ref Gentle FlexModel Gentle Flex、Gentle Flex Pro

EMDN B99

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697737130001LD Basic UDI-DIDate28 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Gentle Flex Pro High Throughput Cell Processing System
Model / Reference
Gentle Flex、Gentle Flex Pro, Gentle Flex
Primary DI / UDI-DI
06977371300012
Basic UDI-DI
697737130001LD
EMDN Code
B99 Haematology and haemotransfusion devices - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000050032
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Cellbri Bio-Innovation Technology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED e5d6c336-6d42-4245-b9df-e79476d2af98 61 fields · synced 22 Oct 2026