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Blood Component Separator

by Sichuan Nigale Biotechnology Co., Ltd. China EUDAMED

Ref 04Model NGL XCF 3000

EMDN B030104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970658701120 Basic UDI-DIDate10 Mar 2025RegisteredStatusUnknown

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Status not known
  • Not covered

European Union — CE/MDD Status not known

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Blood Component Separator
Model / Reference
NGL XCF 3000, 04
Primary DI / UDI-DI
06970658701120
Basic UDI-DI
B-06970658701120
EMDN Code
B030104 Apheresis multiple blood component collection devices
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015825
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Sichuan Nigale Biotechnology Co., Ltd.

See all devices from Sichuan Nigale Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • 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

Sources (1)

  • EUDAMED cb014b61-1b04-493e-826c-c2bd57d84b91 61 fields · synced 22 Oct 2026