Skip to content

Cell-Free DNA/RNA BCT

by Hangzhou MiYin Biotechnology Co., Ltd

Ref BCG-XY-400, BCG-XY-1000Model BCG-XY-400 BCG-XY-1000

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697533032DNA/RNABCTSZ Basic UDI-DI Date2 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Cell-Free DNA/RNA BCT
Model / Reference
BCG-XY-400 BCG-XY-1000, BCG-XY-400, BCG-XY-1000
Primary DI / UDI-DI
06975330320101, 06975330320118
Basic UDI-DI
697533032DNA/RNABCTSZ
EMDN Code
W050299 Devices for samples transport - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000041649
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: General specimen container IVD, no additive/medium

Other devices from Hangzhou MiYin Biotechnology Co., Ltd

Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No